Vice President Quality Assurance
Olema Oncology
June 25, 2026
On-site
Boston, MA
Operations
Vice President, Quality Assurance
Responsibilities:
- Define and drive a pragmatic, 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 significant quality, compliance, and patient safety risks; ensure ongoing inspection readiness.
- Set direction for a scalable Quality Management framework spanning clinical through commercial stages.
- Drive consistency in quality processes, risk management, and data integrity standards; establish quality metrics and reporting.
- Provide GCP oversight, including CRO management to ensure patient safety and data integrity.
- Provide GMP oversight (including CMO/CDMO oversight), and deliver Quality input into CMC, validation, and supply chain readiness.
- Oversee pharmacovigilance quality, ensuring compliance, data integrity, safety surveillance, and inspection readiness.
- Lead regulatory inspection approach and risk-based audit programs across GCP, GMP, and GPV; proactively mitigate quality/compliance risks.
- Partner cross-functionally with Executive Leadership, Regulatory, Clinical, and Manufacturing; represent Quality in executive/external engagements as needed.
Qualifications (Knowledge/Experience/Attributes):
- Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS).
- Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (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 of Quality experience in biotech/pharma; increasing scope/responsibility.
- Significant people management/leadership experience.
- Experience overseeing global vendor networks (CROs, CMOs, CDMOs, PV vendors) and leading/operating across GCP/GMP/GPV.
- Track record supporting clinical-to-late-stage or commercial readiness; leading regulatory inspections and interacting with health authorities.
- Experience implementing/maintaining Quality systems and compliance frameworks.
- Strong leadership, executive communication/influencing, and sound risk-based judgment.
- Ability to operate effectively in a fast-paced, evolving biotech environment; commitment to quality, compliance, and patient safety.
Benefits/Pay:
- Base pay range: $315,000–$340,000 annually (plus equity, bonus, and benefits).
Application instructions:
- Not provided; Olema does not accept agency resumes.
Responsibilities:
- Define and drive a pragmatic, 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 significant quality, compliance, and patient safety risks; ensure ongoing inspection readiness.
- Set direction for a scalable Quality Management framework spanning clinical through commercial stages.
- Drive consistency in quality processes, risk management, and data integrity standards; establish quality metrics and reporting.
- Provide GCP oversight, including CRO management to ensure patient safety and data integrity.
- Provide GMP oversight (including CMO/CDMO oversight), and deliver Quality input into CMC, validation, and supply chain readiness.
- Oversee pharmacovigilance quality, ensuring compliance, data integrity, safety surveillance, and inspection readiness.
- Lead regulatory inspection approach and risk-based audit programs across GCP, GMP, and GPV; proactively mitigate quality/compliance risks.
- Partner cross-functionally with Executive Leadership, Regulatory, Clinical, and Manufacturing; represent Quality in executive/external engagements as needed.
Qualifications (Knowledge/Experience/Attributes):
- Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS).
- Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (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 of Quality experience in biotech/pharma; increasing scope/responsibility.
- Significant people management/leadership experience.
- Experience overseeing global vendor networks (CROs, CMOs, CDMOs, PV vendors) and leading/operating across GCP/GMP/GPV.
- Track record supporting clinical-to-late-stage or commercial readiness; leading regulatory inspections and interacting with health authorities.
- Experience implementing/maintaining Quality systems and compliance frameworks.
- Strong leadership, executive communication/influencing, and sound risk-based judgment.
- Ability to operate effectively in a fast-paced, evolving biotech environment; commitment to quality, compliance, and patient safety.
Benefits/Pay:
- Base pay range: $315,000–$340,000 annually (plus equity, bonus, and benefits).
Application instructions:
- Not provided; Olema does not accept agency resumes.