Senior GCP/PV/GLP QA Manager
Exelixis
8 hours ago
On-site
Alameda, CA
Operations
Essential Duties/Responsibilities
- Assist with the development, implementation, and maintenance of end-to-end QA systems and activities for GCP/GLP operations, including planning and supporting vendor audits and related documentation.
- As QA Core, support QA Partner and assist with development of internal processes and systems for GCP/GVP QA activities.
- Provide direct support to development and clinical study teams; participate in QA planning and implementation to support study operations, including development and approval of the clinical audit schedule.
- Contract, conduct, and support GCP/GVP audits by contractors and support regulatory inspections.
- Develop, track, and manage periodic management reports, including GCP/GVP compliance and QA metrics.
- Independently determine approach to complex compliance issues; rapidly escalate findings with resolution recommendations; verify CAPAs are implemented and documented.
- Support, train internal staff, and oversee GCP/GVP consultants as applicable.
- Implement GCP/GVP QA policies and/or procedures.
- Partner with Regulatory Affairs, Clinical Operations, Translational Medicine, etc.; provide compliance guidance to audited parties.
- Maintain knowledge of current regulation requirements; inform Clinical Development stakeholders of potential organizational impact.
Qualifications
- BS/BA in a related discipline and 9+ years related experience; or MS/MA with 7+ years; or PhD with 2+ years; or equivalent education/experience.
- Typically 6–8 years related CQA, GCP, and/or GVP experience (or combination of experience and education/training), with at least 6+ years progressive experience.
- Biotech or pharmaceutical industry experience preferred.
Knowledge/Skills
- Knowledge of drug development processes.
- Demonstrated GCP/GVP audit conduct and management experience.
- Working knowledge of supporting GCP/GVP preparation and global regulatory filing submission activities.
- Excellent verbal, written, and presentation communication skills.
- Ability to influence others, collaborate, and negotiate feasible solutions.
- Strong technical problem-solving and ability to identify/implement evaluation methods and procedures.
- Ability to interpret and recommend modifications to company/divisional policies.
- Detail-oriented; precision in execution.
- Strong MS Office (Word, Excel, PowerPoint) skills.
Benefits
- 401k with generous company contributions; group medical, dental, and vision coverage; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive plan for field sales); company stock purchase; long-term incentives.
- 15 accrued vacation days (first year), 17 paid holidays (including winter shutdown in December), up to 10 sick days.
Work Conditions
- Onsite; travel as required (15–20%).
- Assist with the development, implementation, and maintenance of end-to-end QA systems and activities for GCP/GLP operations, including planning and supporting vendor audits and related documentation.
- As QA Core, support QA Partner and assist with development of internal processes and systems for GCP/GVP QA activities.
- Provide direct support to development and clinical study teams; participate in QA planning and implementation to support study operations, including development and approval of the clinical audit schedule.
- Contract, conduct, and support GCP/GVP audits by contractors and support regulatory inspections.
- Develop, track, and manage periodic management reports, including GCP/GVP compliance and QA metrics.
- Independently determine approach to complex compliance issues; rapidly escalate findings with resolution recommendations; verify CAPAs are implemented and documented.
- Support, train internal staff, and oversee GCP/GVP consultants as applicable.
- Implement GCP/GVP QA policies and/or procedures.
- Partner with Regulatory Affairs, Clinical Operations, Translational Medicine, etc.; provide compliance guidance to audited parties.
- Maintain knowledge of current regulation requirements; inform Clinical Development stakeholders of potential organizational impact.
Qualifications
- BS/BA in a related discipline and 9+ years related experience; or MS/MA with 7+ years; or PhD with 2+ years; or equivalent education/experience.
- Typically 6–8 years related CQA, GCP, and/or GVP experience (or combination of experience and education/training), with at least 6+ years progressive experience.
- Biotech or pharmaceutical industry experience preferred.
Knowledge/Skills
- Knowledge of drug development processes.
- Demonstrated GCP/GVP audit conduct and management experience.
- Working knowledge of supporting GCP/GVP preparation and global regulatory filing submission activities.
- Excellent verbal, written, and presentation communication skills.
- Ability to influence others, collaborate, and negotiate feasible solutions.
- Strong technical problem-solving and ability to identify/implement evaluation methods and procedures.
- Ability to interpret and recommend modifications to company/divisional policies.
- Detail-oriented; precision in execution.
- Strong MS Office (Word, Excel, PowerPoint) skills.
Benefits
- 401k with generous company contributions; group medical, dental, and vision coverage; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive plan for field sales); company stock purchase; long-term incentives.
- 15 accrued vacation days (first year), 17 paid holidays (including winter shutdown in December), up to 10 sick days.
Work Conditions
- Onsite; travel as required (15–20%).