CL

Clovis Oncology

- NASDAQ:CLVS
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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
1 nasdaq:clvs clovisoncology.com clovisoncology.com Mar 3rd, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Mar 2nd, 2019 10:44PM Mar 2nd, 2019 10:44PM Health Care Pharmaceuticals & Biotechnology
2 nasdaq:clvs clovisoncology.com clovisoncology.com Mar 2nd, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Mar 1st, 2019 10:41PM Mar 1st, 2019 10:41PM Health Care Pharmaceuticals & Biotechnology
3 nasdaq:clvs clovisoncology.com clovisoncology.com Mar 1st, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Feb 28th, 2019 10:40PM Feb 28th, 2019 10:40PM Health Care Pharmaceuticals & Biotechnology
4 nasdaq:clvs clovisoncology.com clovisoncology.com Feb 28th, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Feb 27th, 2019 10:29PM Feb 27th, 2019 10:29PM Health Care Pharmaceuticals & Biotechnology
5 nasdaq:clvs clovisoncology.com clovisoncology.com Feb 27th, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Feb 26th, 2019 10:31PM Feb 26th, 2019 10:31PM Health Care Pharmaceuticals & Biotechnology
6 nasdaq:clvs clovisoncology.com clovisoncology.com Feb 26th, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Feb 25th, 2019 10:38PM Feb 25th, 2019 10:38PM Health Care Pharmaceuticals & Biotechnology
7 nasdaq:clvs clovisoncology.com clovisoncology.com Feb 25th, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Feb 24th, 2019 10:39PM Feb 24th, 2019 10:39PM Health Care Pharmaceuticals & Biotechnology
8 nasdaq:clvs clovisoncology.com clovisoncology.com Feb 24th, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Feb 23rd, 2019 10:42PM Feb 23rd, 2019 10:42PM Health Care Pharmaceuticals & Biotechnology
9 nasdaq:clvs clovisoncology.com clovisoncology.com Feb 23rd, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Feb 22nd, 2019 10:40PM Feb 22nd, 2019 10:40PM Health Care Pharmaceuticals & Biotechnology
10 nasdaq:clvs clovisoncology.com clovisoncology.com Feb 22nd, 2019 12:00AM Manager, GCP QA Open Quality Assurance United Kingdom, England, GB GBR Oct 5th, 2018 12:00AM

Job Summary

The Manager, GCP QA is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. Specifically, this responsibility includes supporting the development, execution and maintenance of risk based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures and clinical trial protocols. Furthermore, the Manager supports deployment of GCP inspection readiness plans as well as fulfilling the assigned responsibilities during GCP inspections. The Manager is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures. Review and approval of clinical trial documentation (e.g. protocols, reports, internal deviations and associated CAPAs, etc.) falls within the Manager’s responsibility. The Manager promotes a GCP compliant environment with internal and external stakeholders while at the same time ensuring established Clovis Oncology Quality Systems are employed.

Roles and Responsibilities

• Participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
• Support deployment of GCP inspection readiness plans and provide support during regulatory authority inspections of Clovis related to GCP.
• Participate in the development of adequate and appropriate responses and resolutions to identified inspection observations.
• Communicate audit and inspection outcomes, effectively. Monitor timely completion of the agreed corrective and preventive actions. Compile metrics, measure trends and identify improvements.
• Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting always with an appropriate sense of urgency.
• Perform detailed review of policies, procedures, work instructions, clinical trial protocols and reports, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
• Attend clinical sub-team and ad hoc meetings internally and externally, as well as investigator meetings as needed, to represent quality assurance expectations and GCP training.
• Continuously remain up-to-date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on quality/ compliance/ regulatory related issues.
• Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives.
• Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
• Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
• Perform other duties as assigned.


Feb 21st, 2019 10:42PM Feb 21st, 2019 10:42PM Health Care Pharmaceuticals & Biotechnology

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