Vice President Quality Assurance
Olema Oncology
June 25, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Vice President, Quality Assurance
Responsibilities:
- Define and drive a pragmatic, phase-appropriate, unified global Quality strategy aligned with the pipeline and corporate objectives.
- Establish quality governance, decision frameworks, escalation pathways, and lead Quality leadership across GCP, GMP, and GPV.
- Foster a culture of quality, integrity, and patient focus; act as escalation point for major quality/compliance/patient safety risks.
- Ensure inspection readiness across clinical, manufacturing, and safety domains.
- Build and evolve scalable Quality Management systems across clinical through commercial stages; drive consistency in risk management and data integrity.
- Oversee clinical quality and CRO management (GCP); oversee GMP quality with appropriate CMO/CDMO oversight.
- Oversee pharmacovigilance quality framework, vendor governance, and safety surveillance (GPV); support benefit-risk evaluation.
- Lead regulatory inspection approach and risk-based audit programs across GCP/GMP/GPV.
- Partner cross-functionally to embed quality and provide actionable quality perspectives.
Qualifications:
- Advanced degree (PhD, PharmD, MS) in Life Sciences or related field.
- Deep knowledge of FDA/EMA/ICH and global GxP/GPV requirements.
- Expertise across GCP, GMP, and GPV Quality; strong understanding of quality systems, governance, and inspection readiness.
- 15+ years Quality experience in biotech/pharma with increasing scope.
- People leadership experience; experience overseeing global CRO/CMO/CDMO/PV vendors.
- Track record supporting clinical-to-late-stage/commercial readiness; experience leading inspections and working with global health authorities; implementing/maintaining Quality systems.
Base pay: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
Responsibilities:
- Define and drive a pragmatic, phase-appropriate, unified global Quality strategy aligned with the pipeline and corporate objectives.
- Establish quality governance, decision frameworks, escalation pathways, and lead Quality leadership across GCP, GMP, and GPV.
- Foster a culture of quality, integrity, and patient focus; act as escalation point for major quality/compliance/patient safety risks.
- Ensure inspection readiness across clinical, manufacturing, and safety domains.
- Build and evolve scalable Quality Management systems across clinical through commercial stages; drive consistency in risk management and data integrity.
- Oversee clinical quality and CRO management (GCP); oversee GMP quality with appropriate CMO/CDMO oversight.
- Oversee pharmacovigilance quality framework, vendor governance, and safety surveillance (GPV); support benefit-risk evaluation.
- Lead regulatory inspection approach and risk-based audit programs across GCP/GMP/GPV.
- Partner cross-functionally to embed quality and provide actionable quality perspectives.
Qualifications:
- Advanced degree (PhD, PharmD, MS) in Life Sciences or related field.
- Deep knowledge of FDA/EMA/ICH and global GxP/GPV requirements.
- Expertise across GCP, GMP, and GPV Quality; strong understanding of quality systems, governance, and inspection readiness.
- 15+ years Quality experience in biotech/pharma with increasing scope.
- People leadership experience; experience overseeing global CRO/CMO/CDMO/PV vendors.
- Track record supporting clinical-to-late-stage/commercial readiness; experience leading inspections and working with global health authorities; implementing/maintaining Quality systems.
Base pay: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.