GCP/GVP QA Director
Exelixis
June 25, 2026
On-site
Alameda, CA
Corporate Functions
Responsibilities:
- Serve as QA Partner for development of internal GCP/GVP processes and systems.
- Support development and clinical study teams; participate in QA planning/implementation, including clinical audit schedule, contracting of GCP/GVP audits to contractors, conducting audits, and regulatory inspections.
- Develop, track, and manage periodic management reports with key GCP/GVP compliance and QA metrics.
- Determine approach to complex compliance issues; 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 procedures.
- Partner with Regulatory Affairs, Clinical Operations, Translational Medicine, etc., provide compliance guidance to audited parties.
- Maintain knowledge of current regulations and inform Clinical Development stakeholders of potential organizational impact.
Qualifications:
- BS/BA in related discipline + 13+ years; or MS/MA + 11+ years; or PhD + 8+ years; or equivalent.
- 13+ years relevant pharmaceutical/biotech experience.
- 8+ years GCP/GVP/Drug Safety Quality Assurance experience.
- Experience developing business strategies, metrics, and continuous improvements.
Skills/Abilities:
- Drug development process knowledge; GCP/GVP audit conduct/management.
- Knowledge of global regulatory filing preparation/submission.
- Strong communication and ability to influence/negotiation; technical problem-solving.
- Expertise in Global Regulatory Requirements and GxP/GVP.
- Strong attention to detail; proficient in MS Office (Word/Excel/PowerPoint).
Benefits (as stated): 401(k) with company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus; stock purchase; long-term incentives; 15 vacation days (year 1); 17 paid holidays (incl. winter shutdown); up to 10 sick days.
Application instruction: If you need accommodation during application/recruitment, email recruiting@exelixis.com.
- Serve as QA Partner for development of internal GCP/GVP processes and systems.
- Support development and clinical study teams; participate in QA planning/implementation, including clinical audit schedule, contracting of GCP/GVP audits to contractors, conducting audits, and regulatory inspections.
- Develop, track, and manage periodic management reports with key GCP/GVP compliance and QA metrics.
- Determine approach to complex compliance issues; 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 procedures.
- Partner with Regulatory Affairs, Clinical Operations, Translational Medicine, etc., provide compliance guidance to audited parties.
- Maintain knowledge of current regulations and inform Clinical Development stakeholders of potential organizational impact.
Qualifications:
- BS/BA in related discipline + 13+ years; or MS/MA + 11+ years; or PhD + 8+ years; or equivalent.
- 13+ years relevant pharmaceutical/biotech experience.
- 8+ years GCP/GVP/Drug Safety Quality Assurance experience.
- Experience developing business strategies, metrics, and continuous improvements.
Skills/Abilities:
- Drug development process knowledge; GCP/GVP audit conduct/management.
- Knowledge of global regulatory filing preparation/submission.
- Strong communication and ability to influence/negotiation; technical problem-solving.
- Expertise in Global Regulatory Requirements and GxP/GVP.
- Strong attention to detail; proficient in MS Office (Word/Excel/PowerPoint).
Benefits (as stated): 401(k) with company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus; stock purchase; long-term incentives; 15 vacation days (year 1); 17 paid holidays (incl. winter shutdown); up to 10 sick days.
Application instruction: If you need accommodation during application/recruitment, email recruiting@exelixis.com.