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Clovis Oncology, Inc. Manager, GCP QA in Boulder, Colorado

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.

Qualifications

• Demonstrated knowledge of the drug development process (early through late stages), trial design, data and trial management procedures. • Demonstrated audit conduct experience is required. • Experience supporting regulatory authority inspections is required. • Ability to compile and interpret quality metrics. • Current and strong working knowledge and application of international requirements of GCP compliance initiatives and regulations globally applicable to the conduct of clinical trials. • Working knowledge of preparation and submission activities, specifically in relation to GCP, for regulatory filings in USA and EU. • Excellent verbal and written communication skills with the ability to work well in teams or independently and able to prioritize work, manage multiple projects while maintaining quality. • Strong analytical and writing skills to identify issues, solve problems and document them appropriately. • Strong organizational and project management skills, attention to detail, and professionalism required. Ability to manage and coordinate multiple projects and assignments in a demanding fast-paced environment with changing priorities and activities. • Ability to influence others as part of a collaborative team and negotiate effective solutions; strong interpersonal and social skills. • Ability to deal with ambiguity. Creative and pragmatic approach to problem solving and keeping things simple. • Consistently exercises discretion and independent, sound judgment in the performance of the duties described above. • Computer literacy in Microsoft Office Suite (MS Word, Excel and PowerPoint).

Education and Experience

• Bachelors or Master’s degree in a scientific or life sciences discipline, or equivalent. A healthcare background and/or an advance degree preferred. • A minimum of 6+ years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role, clinical monitoring or equivalent with at least 3 years in quality. • GCP auditing experience is required. • Previous participation in regulatory authority inspections is highly desired.

Working Conditions

• This is an office-based position with considerable time required working in the office rather than remotely, approximately 50% in the office. • Depending on the location of the successful candidate, significant travel (up to 40%) may be required as the client base is focused in the California and United Kingdom offices.

Qualifications

• Demonstrated knowledge of the drug development process (early through late stages), trial design, data and trial management procedures. • Demonstrated audit conduct experience is required. • Experience supporting regulatory authority inspections is required. • Ability to compile and interpret quality metrics. • Current and strong working knowledge and application of international requirements of GCP compliance initiatives and regulations globally applicable to the conduct of clinical trials. • Working knowledge of preparation and submission activities, specifically in relation to GCP, for regulatory filings in USA and EU. • Excellent verbal and written communication skills with the ability to work well in teams or independently and able to prioritize work, manage multiple projects while maintaining quality. • Strong analytical and writing skills to identify issues, solve problems and document them appropriately. • Strong organizational and project management skills, attention to detail, and professionalism required. Ability to manage and coordinate multiple projects and assignments in a demanding fast-paced environment with changing priorities and activities. • Ability to influence others as part of a collaborative team and negotiate effective solutions; strong interpersonal and social skills. • Ability to deal with ambiguity. Creative and pragmatic approach to problem solving and keeping things simple. • Consistently exercises discretion and independent, sound judgment in the performance of the duties described above. • Computer literacy in Microsoft Office Suite (MS Word, Excel and PowerPoint).

Education and Experience

• Bachelors or Master’s degree in a scientific or life sciences discipline, or equivalent. A healthcare background and/or an advance degree preferred. • A minimum of 6+ years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role, clinical monitoring or equivalent with at least 3 years in quality. • GCP auditing experience is required. • Previous participation in regulatory authority inspections is highly desired.

Working Conditions

• This is an office-based position with considerable time required working in the office rather than remotely, approximately 50% in the office. • Depending on the location of the successful candidate, significant travel (up to 40%) may be required as the client base is focused in the California and United Kingdom offices.

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