Vice President Quality Assurance
Olema Oncology
August 08, 2026
On-site
Cambridge, MA
Operations
Vice President, Quality Assurance
Responsibilities:
- Define and drive a phase-appropriate, unified Quality strategy aligned with the pipeline and corporate objectives.
- Establish Quality governance, decision-making frameworks, and escalation pathways.
- Lead and develop Quality leadership across GCP, GMP, and GPV.
- Foster a culture of quality, integrity, and patient focus; act as escalation point for quality/compliance/patient safety risks.
- Ensure inspection readiness across clinical, manufacturing, and safety domains.
- Set direction for a scalable, integrated Quality Management framework and evolve Quality systems.
- Drive consistency in quality processes, risk management, and data integrity standards; establish quality metrics/reporting.
- Oversee clinical quality and CRO management; partner with Clinical/Regulatory for inspection-ready programs/submissions.
- Oversee GMP Quality including CMO/CDMO oversight and inspection preparedness; provide Quality input into CMC/validation/supply chain readiness.
- Oversee pharmacovigilance quality framework; govern PV systems/vendors; support benefit-risk evaluation.
- Lead regulatory inspections and risk-based audit programs across GCP/GMP/GPV; mitigate quality/compliance risks.
- Partner cross-functionally to embed quality and represent Quality in executive discussions.
Qualifications:
- PhD, PharmD, or MS (Life Sciences or related).
- Deep knowledge of FDA, EMA, ICH, and global GxP and GPV requirements.
- Expertise across GCP, GMP, and GPV Quality; quality systems, governance, and inspection readiness.
- Working knowledge of oncology drug development.
- 15+ years Quality experience in biotech/pharma with increasing scope.
- People management/leadership experience.
- Experience overseeing global vendors (CROs, CMOs, CDMOs, PV vendors).
- Experience leading regulatory inspections and interacting with global health authorities.
- Experience implementing/maintaining Quality systems and compliance frameworks.
Skills/Attributes:
- Leadership, executive communication/influencing.
- Sound judgment in complex, risk-based environments; able to operate in a fast-paced biotech environment.
- Commitment to quality, compliance, and patient safety.
Benefits/Compensation:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- No agency resumes; not responsible for fees related to unsolicited resumes.
Responsibilities:
- Define and drive a phase-appropriate, unified Quality strategy aligned with the pipeline and corporate objectives.
- Establish Quality governance, decision-making frameworks, and escalation pathways.
- Lead and develop Quality leadership across GCP, GMP, and GPV.
- Foster a culture of quality, integrity, and patient focus; act as escalation point for quality/compliance/patient safety risks.
- Ensure inspection readiness across clinical, manufacturing, and safety domains.
- Set direction for a scalable, integrated Quality Management framework and evolve Quality systems.
- Drive consistency in quality processes, risk management, and data integrity standards; establish quality metrics/reporting.
- Oversee clinical quality and CRO management; partner with Clinical/Regulatory for inspection-ready programs/submissions.
- Oversee GMP Quality including CMO/CDMO oversight and inspection preparedness; provide Quality input into CMC/validation/supply chain readiness.
- Oversee pharmacovigilance quality framework; govern PV systems/vendors; support benefit-risk evaluation.
- Lead regulatory inspections and risk-based audit programs across GCP/GMP/GPV; mitigate quality/compliance risks.
- Partner cross-functionally to embed quality and represent Quality in executive discussions.
Qualifications:
- PhD, PharmD, or MS (Life Sciences or related).
- Deep knowledge of FDA, EMA, ICH, and global GxP and GPV requirements.
- Expertise across GCP, GMP, and GPV Quality; quality systems, governance, and inspection readiness.
- Working knowledge of oncology drug development.
- 15+ years Quality experience in biotech/pharma with increasing scope.
- People management/leadership experience.
- Experience overseeing global vendors (CROs, CMOs, CDMOs, PV vendors).
- Experience leading regulatory inspections and interacting with global health authorities.
- Experience implementing/maintaining Quality systems and compliance frameworks.
Skills/Attributes:
- Leadership, executive communication/influencing.
- Sound judgment in complex, risk-based environments; able to operate in a fast-paced biotech environment.
- Commitment to quality, compliance, and patient safety.
Benefits/Compensation:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- No agency resumes; not responsible for fees related to unsolicited resumes.