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nasdaq:ptla
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www.portola.com
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www.portola.com
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May 21st, 2020 12:00AM
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Manager, Clinical Quality Assurance
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Open
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Quality
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South San Francisco, CA, United States
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South San Francisco
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CA
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USA
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May 20th, 2020 12:00AM
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Manager, Clinical Quality Assurance Requisition ID: 337 Position SummaryThe Manager, Clinical Quality Assurance will be responsible for developing and/or approving clinical quality systems/procedures and ensuring quality oversight. Responsibilities will cover all aspects of clinical and nonclinical studies and will require a focus on Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practices (GVP) regulations and guidance. ResponsibilitiesContribute to strategic Clinical QA planning and risk assessmentLead and co-audit GCP/GLP/PVG compliance audits, including clinical investigator sites, contract research organizations (CROs) and contract clinical laboratories to determine compliance status and identify compliance risksAssist in the development of CQA audit plans (internal and external) and implements the actions necessary to ensure processes are conducted in accordance with the audit plan, GCP/GLP/GVP guidelines and regulatory requirementsEnsure all audits are followed-up and corrective actions are completed, implemented, and verifiedConduct investigations of GCP-related issues (i.e., non-compliance, quality events) and work with subject matter experts to develop corrective and preventative action plansAssist in developing or overseeing CQA quality systems and support department infrastructure development; assist with creation/revision of appropriate CQA SOPsProvide GCP guidance to internal departments for all phases of clinical drug developmentPromote/advance quality awareness throughout the organization; coordinate and provide GCP/GLP/GVP trainingWork in collaboration with clinical sites, Clinical Operations, Clinical Development, Pharmacovigilance, and Regulatory Affairs and other stakeholders to ensure compliance with GxPs and to maintain inspection readiness; attend study management team meetings, as assignedReview regulatory submission documents (Clinical Study Report and Integrated Safety/Efficacy Summaries) and other essential documents (protocols, informed consents, investigator brochure, and study plans)Develop metric reports for CQA management of all issues related to audit results and other clinical compliance issuesManage audit consultants Performs other duties as assigned QualificationsMinimum BA/BS degree preferably in biological sciences, pharmacy, or related field6 years of pharmaceutical experience, preferably in Quality Assurance or a clinical setting and 3+ years direct US and international Clinical QA auditing experience, preferably familiar with GLP/ GPV QAExcellent working knowledge of GCP-related requirements, proficiency with regulatory and ICH guidelinesBroad experience in the pharmaceutical industry with a strong clinical development backgroundDetail oriented with Quality Assurance and/or Clinical Development background with analytical and problem solving skillsAbility to analyze and reconcile moderate-to-complex GCP compliance issues independently and in a group settingAbility to travel 30% of time, or as required Portola Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.
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May 20th, 2020 11:49PM
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May 20th, 2020 11:49PM
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Portola Pharmaceuticals
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Health Care
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Pharmaceuticals & Biotechnology
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