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Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated Ticker Sector Ticker Industry
nasdaq:endp www.endo.com www.endo.com Jul 2nd, 2019 12:00AM Associate Process Engineer Open Production Support Chestnut Ridge, NY, United States Chestnut Ridge NY USA May 29th, 2019 12:00AM Job Summary - a concise overview of the jobThe Process Engineer I, under direct supervision, performs various duties related to pharmaceutical construction, engineering, manufacturing / packaging process, and product development projects.All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Process engineering duties within a single location. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeQualification Protocols§  Prepares and executes engineering study/equipment performance qualification protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products.§  Coordinates with Facilities, Engineering, Manufacturing, Packaging, Product Development, Analytical Services, RA, and QA to initiate manufacturing and packaging experimental / feasibility study / validation projects for marketed and new products.25%Technical Transfer§  Performs or assists with on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.25%Formulation Development§  Conducts or assists with formulation development and evaluation for marketed and new products.25%Troubleshooting§  Troubleshoots the setup and operation of manufacturing/packaging equipment and the process of new R&D projects.§  Conducts investigations on deviations, evaluates, and troubleshoots the manufacturing / packaging equipment and process issues.20%Training§  Conducts training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree in Chemical Engineering or related field required.§  Some relevant pharmaceutical or related experience preferred.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Working knowledge of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.§  Familiarity of regulatory requirements and different guidance documents.§  Analytical test methodology (BU, Assay, CU and dissolution profile, etc.)§  Basic understanding of concepts of equipment qualification/calibration for both wet granulated and directly compressed products.§  Basic understanding of computer validation concepts.§  Basic statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.§  Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific   e.g. coaching, negotiation, calibration, technical writing etc.§  Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.§  Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.§  Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.§  Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.§  Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.§  Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.§  Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.Physical RequirementsPhysical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Employee is occasionally required to climb or balance; must occasionally lift and/or move up to 50 pounds.§  Employee is frequently exposed to moving mechanical parts, and occasionally exposed to outside weather conditions and risk of electrical shock.§  The noise level in the work environment is usually moderate. Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required. Jul 2nd, 2019 06:37AM Jul 2nd, 2019 06:37AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Jul 2nd, 2019 12:00AM Reliability Technician l - Facilities Open Production Support Chestnut Ridge, NY, United States Chestnut Ridge NY USA Jun 5th, 2019 12:00AM Performs facilities reliability maintenance activities in accordance with approved procedures and implements effective corrective maintenance repairs to provide increased reliability.  Learns to identify utility systems and equipment and/or process deviations and refers deviations to the supervisor.  May assist a more senior technician or supervisor in troubleshooting manufacturing equipment problems.  Learns to apply skills and knowledge to increase efficiency, throughput and quality.  May assist in equipment set ups when applicable.  Performs work tasks in such a manner as to not waste material or time.    The Reliability Technician I is enrolled into the Apprenticeship program (Huntsville only).All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Par’s buildings, utilities, manufacturing operations, etc. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeProactive Maintenance§  Learns and performs preventive and predictive maintenance tasks on all facilities’ equipment according to the frequency written in the SOP.§  Performs condition-based monitoring while PMs are being performed, and notes problems or changes in the comment section of the PM form.  §  Adheres to Reliability Centered Maintenance (RCM) strategies utilizing a pro-active approach to minimize equipment downtime.30-60%Reactive Maintenance§  Assists with troubleshooting problems or breakdowns on control valves, motors, pumps, actuator, HVAC controls, boilers, chillers, domestic water, compressed air systems, DI water systems and other facilities equipment in the plant. §  May work on packaging and manufacturing equipment as required.5-20%Master Cleaning§  May Assist in Master Cleanings and/or set-ups of the equipment in manufacturing including breaking down, cleaning, re-assembling, and startup of the machines.0-10%Cleaning, Polishing & Challenging of Tooling§  May be responsible for cleaning and polishing tooling when necessary, including completion of proper paperwork.  Must use rags and/or the grinding machine to correctly clean and polish tooling. 0-10%Teamwork & Collaboration§  Partners with more senior technicians to learn cGMP equipment maintenance. §  Works with others assigned to tasks for the mutual benefit of the employer, team and individual. §  Participates as a team member by contributing to project success and sharing novel insights.  0-5%Training§  Conforms to all training requirements, including company required and utility equipment training.10%Safety§  Follows all applicable SOPs, including, but not limited to, lock-out, tag-out and PPE requirements.continuousProjects§  Completes project assigned work in a timely fashion.5%Meetings§  Attends all Production, Maintenance and other meetings when mandatory.0-5%Other§  Performs other duties as assigned.continuousTotal100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  HS diploma or equivalent with related certification, or§  HS diploma or equivalent with 2-4 years’ related experience.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, cGMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Can develop and apply basic knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.§  Ability to learn cGMP regulations.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Basic understanding and competence in all the following:§  Basic electricity§  Basic plumbing§  Basic construction§  Basic Maintenance§  Basic Pneumatics§  May require added knowledge in one or more of the following areas:§  Electrical§  Hydraulic§  Pneumatics§  Mechanical§  PLCs§  Ability to learn pharmaceutical maintenance and cGMP processes.§  Ability to learn to perform PM tasks and read basic schematics, technical drawings and/or blueprints.§  Basic math, writing skills, and excellent problem solving abilities.§  Basic computer skills.§  Ability to use hand tools.§  Control Precision - ability to quickly and repeatedly adjust the controls of a machine to exact positions.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Must be able to stand for long periods of time (12 hour shifts).§  Lift at least 50 pounds.§  Climb ladders.§  Wear a respirator and pass associated respirator tests and/or requirements.§  Able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.§  Reaction Time - ability to quickly respond with manual dexterity to a signal (sound, light, picture) when it appears.§  Dexterity - ability to make precisely coordinated movements of the fingers of one or both hands to grasp, manipulate, or assemble very small objects.§  Vision - ability to see details at close range (within a few feet of the observer).§  Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness. Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required. Jul 2nd, 2019 06:37AM Jul 2nd, 2019 06:37AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Jul 2nd, 2019 12:00AM Manager, Technical Writing Open Production Support Chestnut Ridge, NY, United States Chestnut Ridge NY USA Jun 20th, 2019 12:00AM Job Summary - a concise overview of the jobThe Manager, Technical Writing will manage a team of Technical Writers in drafting and editing detail Manufacturing Batch Records, Master Packaging Records and authoring protocols and reports. The incumbent will represent the technical writing team in cross-functional meetings with the Quality Unit, Research & Development, Regulatory Affairs and Operations to support new product submissions, validation, site transfers, launches, marketed products, and technical support.  The Manager will drive career growth and opportunity for team members and have excellent project management, organizational, writing and communication skills. The incumbent may also provide basic technical writing training to other staff in the department or other departments as needed.  All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Primary scope includes providing support to the Technical Operations teams in Chestnut Ridge & Chennai; will support additional sites as needed. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeCollaborations & Management of Manufacturing Batch Records§  Analyzes data to determine, recommend, and plan processes in the technical writing group to drive quality and efficiencies based on input from cross-functional departments.§  Creates, maintains, and follows consistent writing style standards across production records to establish best practices.§  Manages subordinate staff in the day-to-day performance of their jobs.§  Ensures project milestones and goals are met.§  Develops appropriate tracking metrics to monitor cycle time of batch records to ensure compliance with quality improvement goals.§  Interacts frequently with departmental leaders to provide perspective on timing of controlled documents, change control, and FDA filings.60%Compliance§  Identifies compliance risks to management; provides remediation proposals and supports solution implementation for document control issues.§  Provides self-check audits and immediate support for regulatory audits.§  Contributes to the assessment of validation compliance risk.§  Reviews and approves change controls for implementing planned changes that can affect product quality and/or regulatory compliance.10%Packaging Validation§  Manages and supports packaging validation of new product launches, submission/evaluation batches, site transfers and process improvements.§  Drafts and authors packaging validation protocols and reports.§  Manages the development of standard work practices and/or SOPs to ensure a high and consistent level of quality.§  Writes/updates packaging validation compliance standard operating procedures (SOPs).25%Other§  Performs other duties as assigned.§  Contributes to general projects.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  BS degree in Chemistry, Biology or Pharmaceutical Sciences plus a minimum of 7 years’ relevant experience is required.§  Strong technical and quality background in the pharmaceutical industry is preferred.§  Technical and quality background related to pharmaceuticals.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Knowledge of all current state, federal and local standards and regulations, e.g., cGMP, GLP, OSHA, EEOC, EPA, and DEA.§  Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Must have demonstrated technical writing skills.§  Must be able to interact with production quality and management personnel to gather important information.§  Ability to identify the developmental needs of others and provide coaching, mentoring, and encouragement to help improve their knowledge or skills.§  Customer/stakeholder focused with the ability to understand business plans and operating environment.§  Strong focus on quality with the proven ability to apply a high degree of integrity.§  Strong leadership, team building, and communication skills.§  Demonstrated project management and facilitation skills.§  Clear problem-solving and decision-making skills.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to walk across plant/warehouse.  Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such Jul 2nd, 2019 06:37AM Jul 2nd, 2019 06:37AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Jul 17th, 2019 12:00AM Associate Product Manager Open Marketing Montréal, Canada Montreal QC CAN Jul 9th, 2019 12:00AM Associate Product Manager Position SummaryThe Associate Product Manager’s responsibility is to assist the Associate Director with the development and execution of the marketing strategies and plans that will result in the achievement of the short and long term profit objectives of the Paladin Base Business brands.   Reports ToAssociate Director, Market Analytics and base business Specific Responsibilities Assist with the development, monitoring and updating of short and long term sales forecasts for brands;Under supervision of the Associate Director, take an active role in the development and recommendation of marketing plans that will achieve forecasts;Monitor and evaluate market conditions, program execution and sales performance vs. expectation;  Use initiative, insight and judgment to proactively recommend corrective and/or incremental actions;Manage brand P&L to deliver on profit commitments;Monitoring of hospital tenders, development of pricing strategies and preparation of tender submissions for the hospital buying groups. Characteristics of a Good Candidate Leadership Priority settingProblem Solving / Analytical SkillsInitiative and Follow throughExcellent interpersonal Skills Candidate ProfileExperience, Training and EducationRequiredUniversity degree;2 to 4 years’ experience in a similar position;Excellent communication skills– Written and oral both in French and English;Strong computer skills. AssetUniversity degree with a focus on Marketing or Management;Previous work experiences in marketing, sales, packaged goods or pharmaceutical products;Understanding of IMS/Brogan data;Knowledge of other database software (ex: Access) and financial information systems (ex: SAP).Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Jul 17th, 2019 05:36AM Jul 17th, 2019 05:36AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Jul 17th, 2019 12:00AM Chef de produits associé Open Marketing Montréal, Canada Montreal QC CAN Jul 16th, 2019 12:00AM Chef de produits associé Sommaire du posteLa responsabilité du chef de produit associé consiste à assister le directeur associé dans l’élaboration et la mise en œuvre des stratégies et des plans marketing permettant d’atteindre les objectifs de profit à court et à long terme des marques de Paladin.Supérieur immédiatDirecteur associé, Données de marché et produits de base Responsabilités Assister pour le développement, le suivi et la mise à jour des prévisions de ventes à court et à long terme pour les marques;Sous la supervision du directeur associé, jouer un rôle actif dans l'élaboration et la recommandation de plans de marketing permettant d'atteindre les prévisions;Surveiller et évaluer les conditions du marché, l'exécution du programme et le rendement des ventes par rapport aux attentes;Faire preuve d'initiative, de perspicacité et de jugement pour recommander de manière proactive des actions correctives et / ou progressives;Gérer le compte de résultat de la marque afin de respecter ses engagements en matière de profit;Faire le suivi des appels d'offres des hôpitaux, le développement de stratégies de tarification et préparer des soumissions pour les groupes d'acheteurs d'hôpitaux.  Caractéristiques d’un bon candidat Leadership Sens des prioritésRésolution de problèmes / compétences analytiquesInitiative et suiviExcellent entregent Profil du candidatExpérience, formation et éducationRequisDiplôme universitaire;2 à 4 ans d’expérience dans un poste similaire;Excellentes compétences en communication - écrit et oral, en français et en anglais;Solides compétences en informatique. AtoutsDiplôme universitaire axé sur le marketing ou la gestion;Expérience de travail dans le marketing, la vente, les produits emballés ou les produits pharmaceutiques;Compréhension des données IMS / Brogan;Connaissance d'autres logiciels de bases de données (ex: Access) et de systèmes d'information financière (ex: SAP).NOTE : Le masculin est utilisé afin d’alléger le texte et comprend le féminin lorsque le contexte l’indique.Seuls les candidats retenus seront contactés. Jul 17th, 2019 05:36AM Jul 17th, 2019 05:36AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Jul 17th, 2019 12:00AM Specialty Sales Representative – Oncology/Parkinson Open Sales Montréal, Canada Montreal QC CAN Mar 16th, 2019 12:00AM Specialty Sales Representative – Oncology/Parkinson(Montreal and Ottawa)  Reports ToNational Sales Manager, Specialty Sales (Oncology/Parkinson) Position Summary  We are currently looking for a Specialty Sales Representative for Montreal and Ottawa territories. The Specialty Sales Representative's responsibility is to develop sales in the major centers of their respective territories by identifying and acting on sale opportunities, developing superior customer relationships and effectively positioning the company's products to meet customer needs. The position will require travel and proven large territory management skills are essential. The successful candidate will also be responsible for:Analyzing territory results for both historical and current results to identify sales opportunities;Develop a plan of action that will achieve sales objectives and develop the territory to its full potential;Execute the plan of action, achieving strong levels of reach and frequency among key customers;Develop a superior level of product knowledge in order to best understand physician needs and how the company's products can be best positioned to address them;Plan and execute selling events and continuing medical education activities to increase the adoption of the company's products. Characteristics of a Good CandidateAbility to lead without authority;Communications skills;Excellent territory management skills;Ability to review and analyze data/systems/processes to identify and create business opportunities and to improve tactical implementation of strategic goals;Strong business & financial acumen and analytical capabilities;Ability to manage and prioritize work load, multi-task and manage a diverse mix of issues, responsibilities and challenges. Candidate ProfileExperience, Training and Education Required University degree in any of the following areas (science, medicine, pharmacy, business);Professional/work experience in oncology (leukemia) and/or CNS ( Parkinson) (3 years+) with a strong record of achievement;Excellent written and oral communication skills in English and French;Analytical and strategic thinking skills;Excellent territory management skills;Strong computer skills (spreadsheet, database applications, presentation software and word processing); AssetsExperience in promoting to specialist in hospital environment;Established relationships in therapeutic and geographic area.   Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading. Only selected candidates will be contacted. Jul 17th, 2019 05:36AM Jul 17th, 2019 05:36AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Jul 17th, 2019 12:00AM Représentant spécialisé en ventes - Oncologie/Parkinson Open Ventes Montréal, Canada Montreal QC CAN Mar 16th, 2019 12:00AM Représentant spécialisé en ventes – Oncologie/Parkinson (Montréal et Ottawa)  Supérieur immédiatDirecteur national des ventes, Ventes spécialisées (Oncologie / Parkinson) Résumé du posteNous sommes présentement à la recherche d’un Représentant spécialisé en ventes pour les territoires de Montréal et d’Ottawa.La responsabilité du représentant spécialisé en ventes consiste à développer les ventes dans leurs territoires respectifs en identifiant et en exploitant les opportunités de vente, en créant d’excellentes relations avec ses clients et en positionnant efficacement les produits de l'entreprise afin de répondre aux besoins des clients. Le poste exige des déplacements et des aptitudes éprouvées pour la gestion d'un grand territoire sont essentielles.Le candidat retenu sera également responsable de:Analyser les cibles principales et secondaires du territoire afin de déterminer les débouchés commerciaux;Développer un plan d'action explicite qui permettra d'atteindre les objectifs de vente et de développer le plein potentiel de vente du territoire;Mettre en œuvre le plan d’action en atteignant de hauts degrés de rayonnement et de fréquence auprès de la clientèle clé;Acquérir un degré supérieur de connaissance des produits de manière à mieux comprendre les besoins des médecins et des patients et à être en mesure de mieux positionner les produits de l’entreprise pour répondre à ceux-ci;Planifier et réaliser des événements de vente, y compris des activités de formation médicale continue afin d'accroître l’adoption des produits de l’entreprise. [...]Caractéristiques d’un bon candidatCapacité à diriger sans autoritéCompétences en communicationExcellentes compétences en gestion de territoireCapacité à examiner et à analyser les données / systèmes / processus afin d'identifier et de créer des opportunités commerciales et d'améliorer la mise en œuvre tactique des objectifs stratégiquesFort sens des affaires et financier et capacités d'analyseAptitude à gérer et à hiérarchiser la charge de travail, à exécuter plusieurs tâches à la fois et à gérer une diversité de problèmes, de responsabilités et de défis Profil du candidatExpérience, formation et éducation RequisDiplôme universitaire dans l’un des domaines suivants (sciences, médecine, pharmacie, commerce).Expérience professionnelle en oncologie (leucémie) et /ou SNC (Parkinson) (3 ans et plus) avec de solides réalisations.Excellentes compétences en communication écrite et orale, en anglais et en français.Aptitudes à la réflexion analytique et stratégique.Excellentes compétences en gestion de territoire.Solides compétences en informatique (tableur, applications de base de données, logiciel de présentation et traitement de texte). AtoutsExpérience dans la promotion auprès de spécialiste en milieu hospitalier;Relations établies dans la zone thérapeutique et géographique.  NOTE : Le masculin est utilisé afin d’alléger le texte et comprend le féminin lorsque le contexte l’indique. Seuls les candidats retenus seront contactés. Jul 17th, 2019 05:36AM Jul 17th, 2019 05:36AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Jul 17th, 2019 12:00AM Principal Quality Auditor, GMP Audit Open Quality & Compliance Dublin, Ballsbridge, Ireland Ballsbridge Co. Dublin IRL May 1st, 2019 12:00AM Job Description Job TitlePrincipal Quality Auditor, GMP AuditCompanyPar PharmaceuticalFunctionQuality Location(s)VariousDepartmentCompliance and Vendor QualityDirect Reports (list)N/AReports to (title)VariousDate Submitted  Job Summary - a concise overview of the jobIndependently performs quality audits of sterile drug product manufacturers, contractors and suppliers that support marketed drug products to ensure products, controls, procedures and processes meet quality standards.  Prepares audit reports and communicates findings to external and internal stakeholder.  Able to act completely independently as a QA auditor.  All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Audits, across multiple sites, drug product manufacture, suppliers of API, excipients, packaging components, and firms providing GMP services such as laboratories and others as required.  Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeCompliance Audits(external)Independently conducts external audits, acting as Lead Auditor of an audit team, or participating as an external audit team member.Provide sterile expertise and experience  in auditingAble to perform high profile due diligence audit for corporate management.Schedules audit activities and develop audit agenda.Independently performs evaluations of quality systems and practices to identify potential problems such as Non-Conformance to applicable SOPs and Quality Standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.Prepares audit reports and communicates findings to external and internal stakeholders.Tracks audit responses and auditee’s CAPA until completion and closeout.80%Corporate Enterprise Audits(internal)Acts as Lead Auditor for the Endo sterile audit team for all internal audits.Schedules audit activities with the internal site and provide audit agenda.Performs evaluations of quality systems and practices to identify potential problems such as Non-Conformance to applicable SOPs and quality standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.Prepares audit reports and communicates findings to internal stakeholders.Tracks audit responses and auditee’s CAPA until completion and closeout.10%Regulatory Inspection SupportProvides document support for regulatory audits and mock inspections.Stays up to date on current FDA and EU sterile manufacturing trends5%Compliance Department SupportLeads and/or supports cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards.Becomes knowledgeable through experience of Endo supply chain. Act as source of information on all Quality issues with Endo Supply chain vendors. Participates in the development of QA programs, policies, procedures and controls.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and certifications required for the job5-10 years sterile manufacturing experience in either quality or manufacturing (supervisory experience desired).  5-10 years Microbiology laboratory experience also acceptable.Minimum of a BS degree in Science or Pharmaceutical studies with a minimum of 8 years’ experience in a pharmaceutical manufacturing or Quality Assurance environment.ASQ-CQA or ASQ-CQE certified desired.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Possesses a technical and quality background related to sterile pharmaceuticals.Has solid experience and technical expertise in 4 or more audit areas, such as API, Micro Lab, Sterile drug product, Contract Pkg., Mock PAI, etc.Has thorough knowledge of current standards and regulations related to pharmaceutical dosage forms/devices, (e.g., cGMP, GLP, ICH guidelines and guidance documents) and how to apply them to products pending release, and marketed products.Demonstrates the ability to review investigations, change control, analytical data, test reports, batch records and certificates of analysis and other technical documents.Demonstrates the ability to conduct GMP audits of sterile drug product and/or medical device manufacturers, as well as manufacturers of chemical raw materials and packaging components.Demonstrates the ability to conduct focused quality incident investigations.Shows ability to train new auditors.Skills & AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific      e.g. coaching, negotiation, calibration, technical writing etc.Strong ability with MS Word, Excel, Power Point and Outlook.Good communication skills - written and verbal.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Walk across factory / warehouse can climb stairs and ladders.Travel – Domestic and International (approx. 20-30%). Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.        Page 1 of 2Customer Focus - Breakthrough Thinking – Collaboration – Accountability Endo Job Description Template - Revised July 2012 Jul 17th, 2019 05:36AM Jul 17th, 2019 05:36AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Jul 17th, 2019 12:00AM Senior Manager, Enterprise Quality Auditing Open Quality & Compliance Dublin, Ballsbridge, Ireland Ballsbridge Co. Dublin IRL May 17th, 2019 12:00AM Job Description Job TitleSenior Manager, Enterprise Quality AuditingCompanyEndo VenturesFunctionQualityLocationDublin, IrelandDepartmentEnterprise Quality Auditing (EQA)Direct Reports (list)2 GMP Auditors (various levels)Reports to (title)Senior Director, Enterprise Quality AuditingDate Submitted2/25/2019 Job Summary - a concise overview of the jobThe Senior Manager, Enterprise Quality Auditing manages internal and external audits for Endo’s branded and Par Pharmaceutical business units and internal manufacturing sites.  Coordination of communication with auditing stakeholders at the various business units and internal manufacturing sites, harmonization of systems and processes for integration of the auditing functions. This role is responsible for developing EQA operational procedures and performing/tracking quality audits to completion. The Senior Manager will liaise with auditing stakeholders at the Endo branded and Par Pharmaceutical business units and internal manufacturing sites for audits scheduling and harmonization of auditing processes and standards.  This individual will ensure the department’s goals are met in support Endo’s vision and Key Values. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Manage the internal and external auditing programs.  Ensure department’s expenditures remain on track and within the approved budget.   Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeAuditingExternal and internal auditing of suppliers/vendors and third parties for materials or services contracted by Endo branded and Par Pharmaceutical’s internal manufacturing sites.Development, revision and implementation of Enterprise Quality Auditing procedures including audit techniques for data integrity assessments, policies, technical papers, risk assessments, business continuity plans and quality agreements.Responsible for communication with stake holders at the various business units and internal manufacturing sites.Responsible for the harmonization of auditing systems and processes to integrate the various business units.Authors, reviews and approves new procedures and/or revision of current procedures relevant to the Enterprise Auditing Quality standards/policies.Ensure audits are performed against domestic and international guidance and regulations as appropriate.Ensure the audit program is compliant with current regulations, internal procedures, requirements and timelines.Ensures timely and accurate communication, escalation of critical audit observations to management, partners, stakeholders, and staff.80%Quality MetricsCollection, collation and reporting of applicable Quality Auditing Performance Metrics.10%People DevelopmentEnsure the continuous development, coaching, and cross training of staff.Establish development plans.Oversee establishment of enhanced auditing training program, auditing standards and auditing development plans.10%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and certifications required for the jobMinimum of a Bachelor of Science or equivalent relevant industry experience, Masters in Life Sciences or Science degree is preferred.12+ years of experience in the pharmaceutical/biotechnology industry.10+ years of experience performing GxP audits.Quality management, demonstrated experience in establishing and overseeing Quality Systems.KnowledgeProficiency in a body of information required for the job  e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Knowledge of FDA GXP, ICH regulations and domestic and international guidelines and industry best practices.In-depth knowledge of cGMPs, GDPs, GLPs, domestic and international regulatory inspections and interaction with the domestic and international regulatory agencies.Deep understanding of the domestic and international pharmaceutical industry with solid working foundation within the regulatory environment, organization, and structure.Skills & AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific     e.g. coaching, negotiation, calibration, technical writing etc.Proficient in the use of current office software to enable accomplishments of the objectives.Influence and motivate other departments to take the lead for communicating, monitoring and ensuring Quality and Compliance within their areas. Strong, professional interpersonal skills including ability to communicate effectively with people individually and in groups; ability to communicate with technical and non-technical colleagues.Organize, prioritize work and deliver on the required deadlines or commitments.Establish and maintain effective business relationships, both internally and with the external partners such as CMOs, Suppliers and Regulatory agencies.Strong managerial skills.Strong writing and communication skills.Achieve Risk Based GMP Outcomes. Detail oriented and ability to translate data into information.Lead, manage and participate in teams with shared responsibility for outcomes and decision-making.Self-motivated to learn from industry groups, current literature and emerging regulatory requirements and/or expectationsDemonstrates exceptional commitment to ethical behavior.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Walking/tour manufacturing sites/laboratories/packaging facilities/warehouses.Business Travel (25-35%). Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.        Page 1 of 3Customer Focus - Breakthrough Thinking – Collaboration – Accountability Endo Job Description Template - Revised April 2013 Jul 17th, 2019 05:36AM Jul 17th, 2019 05:36AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Jul 17th, 2019 12:00AM SVP, Global Supply Chain Operations Open Supply Chain Dublin, Ballsbridge, Ireland Ballsbridge Co. Dublin IRL Apr 24th, 2019 12:00AM Job Description Job TitleSVP, Global Supply Chain Operations CompanyEndoFunctionOperations & ManufacturingLocation(s)Dublin, IrelandDepartmentSupply ChainDirect Reports (list)8 direct reportsReports to (title) President, Endo Ventures Date SubmittedJob CodeBandDate ReviewedBenchmarkASC000-EXEEO1.2FLSA  (USA only)Exempt Job Summary - a concise overview of the job The SVP, Global Supply Chain Operations has leadership responsibility for the combined functions of Branded and Generic Supply Chain and is responsible for developing the overall global strategy.  The primary objective is to drive supply chain planning and procurement of raw materials to distribution of finished product.  This includes but is not limited to API, drug substance, drug product or process contract manufacturing as well as packaging and labelling.  Accountable for strategic and supply-related matters involving all acquired and/or in-licensed assets that may be added to the Branded Pharmaceuticals portfolio. Provides leadership to a cross-functional team for the implementation of developed source strategies and the effective management of global Contract Manufacturing Organizations (CMOs).  Activities include developing and implementing capacity and supply strategies in support of the needs of the products; coordination and oversight of activities of subject matter experts in the areas of technical services, operations (i.e. scheduling, forecasting, materials management) and packaging and labeling matters required to support products; communication to key stakeholders such as, Business Units, Quality Assurance, Regulatory Affairs, Business Development, and Research and Development. Also leads the global design and implementation of SAP (Supply Chain Management and Quality Management module, to include Master Data) for the Branded Pharmaceuticals business.  All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Accountable for delivery of strategic global supply plan and network strategy for >$1B in revenueAccountable for planning and procurement of $400M in raw material spendAccountable for >$30M annual distribution and transportation spend Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeLeadershipLeads the combined brand and generic Supply Chain activities, establishes performance metrics and monitors performance against company strategic objectivesAccountable for the timely, effective and quality supply of branded and generic pharmaceuticals to meet short and long-term strategies and demandProvides input and recommendations to the Supply Chain strategic plan that addresses supply/capacity needs and continuous improvementEnsures compliance with cGMP’s, pharmaceutical specifications, internal control, and company policies/procedures  40%CMO Operations & Relationship ManagementResponsible for managing CMO relationshipsRequires direct and independent interaction with CMO Leadership team  Overall responsibility for management of manufacturing operations for CMOs supplying drug substance, or drug product, or API or secondary packaging.  Ensures forecasting and planning needs are met Ensures capacity requirementsOversees CMO production and execution of quality/production performance ensuring metrics are being metEnsures implementation and execution by subject matter experts on technical/regulatory needs for the products such as process changes that support existing production and future product/process and product/process enhancements20%Quality and ComplianceCollaborates with cross-functional stakeholders such as Quality, Regulatory, EH&S, to ensure CMOs are in compliance with manufacturing, environmental, safety policies, cGMPs, corporate standards, and all federal and local regulations   Ensures a consistent approach is taken in the evaluation and resolution of quality issues20%Risk ManagementIn collaboration with Quality, Regulatory, and Commercial business partners assesses supply vulnerabilities and plans for mitigation plans20%Continuous ImprovementSupports implementation of continuous improvement initiatives (including Lean Process Excellence) Measures and drives process excellence improvement effortsContinuousLeadership DevelopmentDevelops direct reports and works closely with them to ensure the development of capabilities and succession planning  Conduct ongoing coaching and performance feedback ContinuousTotal100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and certifications required for the jobBachelor's degree in Business, Engineering, Life Sciences or related field from accredited university (MBA or Master’s Degree preferred)Minimum of 15 years of experience in supply chain, manufacturing and/or packaging related experience in regulated environment, with no less than 8 years in Supply ChainExperience managing global suppliersKnowledgeProficiency in a body of information required for the job  e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Must possess knowledge of cGMPs and SOPs applicable to position, along with  21CFR Part 210 and 211 and Part 11Knowledge and understanding of pharmaceutical manufacturing operations, project management, and supply chain standards and principlesKnowledge and demonstrated application of process excellence tools and methodologiesSkills & AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific      e.g. coaching, negotiation, calibration, technical writing etc.Operationally astute, customer-focused, growth-oriented leader with a strong commitment to innovation, quality and regulatory complianceExcellent communication skills, both written and verbalStrong interpersonal skills; ability to work with and influence colleagues at all levels of responsibility and authorityStrategic thinker capable of developing plans to drive improvements Critical thinking skills and the ability to assess issues and to develop and present conclusionsAbility to excel leading cross-functional teams to solve critical business issuesProven contract negotiations skills Ability to multitask and work in a fast pace environment and be a change agentRecognize the importance of meeting business needs and balance cost, quality and customer serviceDevelop high-performance teams across geographically distributed operations, engaging employees and developing talent Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.General office environment25% travel Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.         Page 1 of 3Customer Focus - Breakthrough Thinking – Collaboration – Accountability Endo Job Description Template - Revised July 2012 Jul 17th, 2019 05:36AM Jul 17th, 2019 05:36AM Health Care Pharmaceuticals & Biotechnology

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