Vice President, Quality Assurance
Olema Oncology
June 25, 2026
On-site
San Francisco, CA
Operations
Vice President, Quality Assurance
Responsibilities:
- Define and drive a pragmatic, phase-appropriate unified Quality strategy; establish governance, decision frameworks, and escalation pathways.
- Lead and develop Quality leadership across GCP, GMP, and GPV; foster a culture of quality, integrity, and patient focus.
- Serve as escalation point for significant quality, compliance, and patient safety risks; ensure inspection readiness across clinical, manufacturing, and safety.
- Set direction for a scalable, integrated Quality Management framework and drive consistent quality processes, risk management, and data integrity standards.
- Oversee clinical quality and CRO management (GCP); oversee GMP Quality with CMO/CDMO oversight and inspection preparedness.
- Oversee pharmacovigilance quality framework and vendor governance (GPV); partner cross-functionally on benefit-risk evaluation.
- Lead regulatory inspection approach; ensure risk-based audits across GCP/GMP/GPV; identify/mitigate quality and compliance risks.
- Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing to embed quality.
Qualifications:
- Advanced degree in Life Sciences or related field (PhD, PharmD, MS).
- Deep knowledge of FDA/EMA/ICH and global GxP/GPV requirements; expertise across GCP, GMP, and GPV.
- Strong understanding of Quality systems, governance, and inspection readiness; working knowledge of oncology drug development.
- 15+ years Quality experience in biotech/pharma with increasing scope; significant leadership/people management.
- Experience overseeing CRO/CMO/CDMO/PV vendors; regulatory inspections with global health authorities.
- Strong leadership, executive communication, sound risk-based judgment, ability to operate in a fast-paced biotech environment; commitment to quality/compliance/patient safety.
Compensation:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
Responsibilities:
- Define and drive a pragmatic, phase-appropriate unified Quality strategy; establish governance, decision frameworks, and escalation pathways.
- Lead and develop Quality leadership across GCP, GMP, and GPV; foster a culture of quality, integrity, and patient focus.
- Serve as escalation point for significant quality, compliance, and patient safety risks; ensure inspection readiness across clinical, manufacturing, and safety.
- Set direction for a scalable, integrated Quality Management framework and drive consistent quality processes, risk management, and data integrity standards.
- Oversee clinical quality and CRO management (GCP); oversee GMP Quality with CMO/CDMO oversight and inspection preparedness.
- Oversee pharmacovigilance quality framework and vendor governance (GPV); partner cross-functionally on benefit-risk evaluation.
- Lead regulatory inspection approach; ensure risk-based audits across GCP/GMP/GPV; identify/mitigate quality and compliance risks.
- Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing to embed quality.
Qualifications:
- Advanced degree in Life Sciences or related field (PhD, PharmD, MS).
- Deep knowledge of FDA/EMA/ICH and global GxP/GPV requirements; expertise across GCP, GMP, and GPV.
- Strong understanding of Quality systems, governance, and inspection readiness; working knowledge of oncology drug development.
- 15+ years Quality experience in biotech/pharma with increasing scope; significant leadership/people management.
- Experience overseeing CRO/CMO/CDMO/PV vendors; regulatory inspections with global health authorities.
- Strong leadership, executive communication, sound risk-based judgment, ability to operate in a fast-paced biotech environment; commitment to quality/compliance/patient safety.
Compensation:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.