Vice President, Quality Assurance
Olema Oncology
August 30, 2026
Remote friendly (San Francisco, CA)
United States
Operations
Vice President, Quality Assurance
Responsibilities:
- Define and drive a pragmatic, phase-appropriate, unified Quality strategy aligned with pipeline and corporate objectives.
- Establish governance, decision-making frameworks, and escalation pathways.
- Lead and develop Quality leadership across GCP, GMP, and GPV; ensure accountability.
- Foster a culture of quality, integrity, and patient focus.
- Serve as escalation point for significant quality, compliance, and patient safety risks.
- Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains.
- Set direction for a scalable, integrated, and sustainable Quality Management framework.
- Drive consistency in quality processes, risk management, and data integrity standards.
- Establish quality metrics and reporting for risk visibility and decision-making.
- Oversee clinical quality and CRO management to ensure patient safety and data integrity (GCP).
- Oversee GMP Quality, including CMO/CDMO oversight and inspection preparedness; provide input into CMC/validation/supply chain readiness.
- Oversee pharmacovigilance quality framework for compliance, data integrity, and safety surveillance (PV/GPV).
- Lead regulatory inspection approach and execute risk-based audit programs across GCP, GMP, and GPV.
- Partner cross-functionally to embed quality and provide actionable Quality input.
Qualifications:
- Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS).
- Deep knowledge of FDA, EMA, ICH, and global GxP and GPV requirements.
- Expertise across GCP, GMP, and GPV Quality domains; strong understanding of quality systems and inspection readiness.
- 15+ years of Quality experience in biotech/pharma; increasing responsibility.
- Significant people management experience.
- Experience overseeing global vendors (CROs, CMOs, CDMOs, PV vendors).
- Experience supporting programs from clinical development through late-stage/commercial readiness.
- Experience leading regulatory inspections and interacting with global health authorities.
- Experience implementing and maintaining Quality systems and compliance frameworks.
Benefits/Compensation:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- None provided.
Responsibilities:
- Define and drive a pragmatic, phase-appropriate, unified Quality strategy aligned with pipeline and corporate objectives.
- Establish governance, decision-making frameworks, and escalation pathways.
- Lead and develop Quality leadership across GCP, GMP, and GPV; ensure accountability.
- Foster a culture of quality, integrity, and patient focus.
- Serve as escalation point for significant quality, compliance, and patient safety risks.
- Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains.
- Set direction for a scalable, integrated, and sustainable Quality Management framework.
- Drive consistency in quality processes, risk management, and data integrity standards.
- Establish quality metrics and reporting for risk visibility and decision-making.
- Oversee clinical quality and CRO management to ensure patient safety and data integrity (GCP).
- Oversee GMP Quality, including CMO/CDMO oversight and inspection preparedness; provide input into CMC/validation/supply chain readiness.
- Oversee pharmacovigilance quality framework for compliance, data integrity, and safety surveillance (PV/GPV).
- Lead regulatory inspection approach and execute risk-based audit programs across GCP, GMP, and GPV.
- Partner cross-functionally to embed quality and provide actionable Quality input.
Qualifications:
- Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS).
- Deep knowledge of FDA, EMA, ICH, and global GxP and GPV requirements.
- Expertise across GCP, GMP, and GPV Quality domains; strong understanding of quality systems and inspection readiness.
- 15+ years of Quality experience in biotech/pharma; increasing responsibility.
- Significant people management experience.
- Experience overseeing global vendors (CROs, CMOs, CDMOs, PV vendors).
- Experience supporting programs from clinical development through late-stage/commercial readiness.
- Experience leading regulatory inspections and interacting with global health authorities.
- Experience implementing and maintaining Quality systems and compliance frameworks.
Benefits/Compensation:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- None provided.