Associate GCP/GLP QA Director
Exelixis
June 27, 2026
On-site
Alameda, CA
$177,500 - $251,500 USD yearly
Clinical Research and Development
Essential Duties and Responsibilities:
- Design and coordinate a comprehensive view and align standards on Quality systems across Clinical Quality Assurance.
- Assess current state, identify gaps, develop action plans, implement improvements, and monitor Quality systems and internal processes related to GCP QA activities.
- Develop, track, and manage periodic management reports with track-and-trend data for key Clinical and QA metrics.
- Review and approve Deviations and Corrective and Preventive Actions (CAPAs).
- Partner with Regulatory Affairs, Clinical Operations, and Translational Medicine on compliance issues; provide compliance guidance.
- Maintain knowledge of Health Authority regulations and standards; inform Clinical Development stakeholders of potential organizational impact.
- Represent CQA in internal presentations on quality issues, initiatives, and projects.
- Identify issues and risks, propose options/solutions, and escalate risks in a timely manner.
- Participate in identifying and implementing process and system improvements.
Qualifications (Education/Experience):
- Bachelor’s in science + 11+ years relevant experience; or Master’s + 9+ years; or PhD + 5+ years; or equivalent combination.
- 10+ years relevant experience in pharmaceutical/biotech industries.
- Experience in Good Clinical Practices (highly desired).
- Demonstrated Quality Systems experience (impact analysis and continuous improvement).
- Strong Quality Risk Management knowledge.
- Proficiency with MS Office.
Knowledge/Skills (Required/Preferred):
- Understanding of drug development and QA oversight of clinical trials.
- Working knowledge of Health Authority rules/regulations.
- Ability to apply Quality Risk Management across Quality systems.
- Strong communication skills (verbal/written) and judgment within defined procedures.
Benefits (only if explicitly stated):
- 401k with generous company contributions; medical, dental, vision; life/disability insurance; flexible spending accounts; discretionary annual bonus (or sales incentive plan); company stock; paid vacation/holidays; sick days.
Application Instructions:
- Disability accommodation for application/recruitment: recruiting@exelixis.com
- Design and coordinate a comprehensive view and align standards on Quality systems across Clinical Quality Assurance.
- Assess current state, identify gaps, develop action plans, implement improvements, and monitor Quality systems and internal processes related to GCP QA activities.
- Develop, track, and manage periodic management reports with track-and-trend data for key Clinical and QA metrics.
- Review and approve Deviations and Corrective and Preventive Actions (CAPAs).
- Partner with Regulatory Affairs, Clinical Operations, and Translational Medicine on compliance issues; provide compliance guidance.
- Maintain knowledge of Health Authority regulations and standards; inform Clinical Development stakeholders of potential organizational impact.
- Represent CQA in internal presentations on quality issues, initiatives, and projects.
- Identify issues and risks, propose options/solutions, and escalate risks in a timely manner.
- Participate in identifying and implementing process and system improvements.
Qualifications (Education/Experience):
- Bachelor’s in science + 11+ years relevant experience; or Master’s + 9+ years; or PhD + 5+ years; or equivalent combination.
- 10+ years relevant experience in pharmaceutical/biotech industries.
- Experience in Good Clinical Practices (highly desired).
- Demonstrated Quality Systems experience (impact analysis and continuous improvement).
- Strong Quality Risk Management knowledge.
- Proficiency with MS Office.
Knowledge/Skills (Required/Preferred):
- Understanding of drug development and QA oversight of clinical trials.
- Working knowledge of Health Authority rules/regulations.
- Ability to apply Quality Risk Management across Quality systems.
- Strong communication skills (verbal/written) and judgment within defined procedures.
Benefits (only if explicitly stated):
- 401k with generous company contributions; medical, dental, vision; life/disability insurance; flexible spending accounts; discretionary annual bonus (or sales incentive plan); company stock; paid vacation/holidays; sick days.
Application Instructions:
- Disability accommodation for application/recruitment: recruiting@exelixis.com