Vice President, Quality Assurance
Olema Oncology
August 08, 2026
On-site
San Francisco, CA
Operations
Vice President, Quality Assurance
Responsibilities:
- Define and drive a phase-appropriate, unified global Quality strategy and governance; establish escalation pathways.
- Lead and develop Quality leadership across GCP, GMP, and GPV; foster quality/integrity/patient focus.
- Set scalable Quality Management framework spanning clinical through commercial; standardize risk management and data integrity; define quality metrics.
- Ensure clinical quality (GCP): oversee CRO management and quality approaches to support oncology trials; partner on inspection-ready submissions.
- Ensure manufacturing & commercial readiness (GMP): support scale-up, provide GMP Quality oversight (CMO/CDMO) and inspection preparedness; contribute to CMC/validation/supply chain readiness.
- Ensure pharmacovigilance quality (GPV): oversee PV compliance, data integrity, vendor governance, and benefit-risk evaluation.
- Lead regulatory inspections, risk-based audits across GCP/GMP/GPV, and mitigation of quality/compliance risks.
- Partner cross-functionally and represent Quality in executive/external discussions.
Qualifications:
- Advanced degree (PhD/PharmD/MS) in Life Sciences or related field.
- Deep knowledge of FDA/EMA/ICH global GxP and GPV requirements; expertise across GCP/GMP/GPV; oncology drug development experience.
- 15+ years Quality experience in biotech/pharma with increasing scope; significant people leadership.
- Experience overseeing CRO/CMO/CDMO/PV vendor networks; regulatory inspection leadership.
Compensation/Benefits:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
Responsibilities:
- Define and drive a phase-appropriate, unified global Quality strategy and governance; establish escalation pathways.
- Lead and develop Quality leadership across GCP, GMP, and GPV; foster quality/integrity/patient focus.
- Set scalable Quality Management framework spanning clinical through commercial; standardize risk management and data integrity; define quality metrics.
- Ensure clinical quality (GCP): oversee CRO management and quality approaches to support oncology trials; partner on inspection-ready submissions.
- Ensure manufacturing & commercial readiness (GMP): support scale-up, provide GMP Quality oversight (CMO/CDMO) and inspection preparedness; contribute to CMC/validation/supply chain readiness.
- Ensure pharmacovigilance quality (GPV): oversee PV compliance, data integrity, vendor governance, and benefit-risk evaluation.
- Lead regulatory inspections, risk-based audits across GCP/GMP/GPV, and mitigation of quality/compliance risks.
- Partner cross-functionally and represent Quality in executive/external discussions.
Qualifications:
- Advanced degree (PhD/PharmD/MS) in Life Sciences or related field.
- Deep knowledge of FDA/EMA/ICH global GxP and GPV requirements; expertise across GCP/GMP/GPV; oncology drug development experience.
- 15+ years Quality experience in biotech/pharma with increasing scope; significant people leadership.
- Experience overseeing CRO/CMO/CDMO/PV vendor networks; regulatory inspection leadership.
Compensation/Benefits:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.