Vice President Quality Assurance
Olema Oncology
August 30, 2026
Remote friendly (Cambridge, MA)
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 Quality governance, decision-making frameworks, and escalation pathways
- Lead and develop Quality leadership across GCP, GMP, and GPV; foster accountability
- Foster a culture of quality, integrity, and patient focus; act as escalation point for significant quality/compliance/patient safety risks
- Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains
- Set direction for scalable, integrated Quality Management framework across clinical through commercial stages
- Drive consistency in quality processes, risk management, and data integrity standards; establish quality metrics and reporting
- Ensure Quality approaches support oncology clinical trial execution; oversee clinical quality and CRO management
- Provide Quality input into CMC, validation, and supply chain readiness; oversee GMP Quality, including CMO/CDMO oversight and inspection preparedness
- Oversee pharmacovigilance quality framework; ensure PV systems and vendors are governed and inspection-ready; partner on benefit-risk evaluation
- Lead regulatory inspection approach (preparation and execution) and risk-based audit programs across GCP/GMP/GPV; mitigate quality/compliance risks
- Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing to embed quality; represent Quality in executive and external engagements
Qualifications:
- Advanced degree (PhD, PharmD, MS) in Life Sciences or related field
- Deep knowledge of FDA, EMA, ICH, and global GxP/pharmacovigilance (GPV) requirements
- Expertise across GCP, GMP, and GPV Quality; strong understanding of Quality systems, governance, and inspection readiness
- Working knowledge of oncology drug development
- 15+ years Quality experience in biotech/pharma; people management leadership experience
- Experience overseeing global vendors (CROs, CMOs, CDMOs, PV vendors)
- Demonstrated GCP/GMP/GPV experience; track record from clinical development through late-stage/commercial readiness
- Experience leading regulatory inspections and interacting with global health authorities; implementing/maintaining Quality systems and compliance frameworks
Attributes:
- Ability to lead/develop senior leaders; executive communication and influencing skills
- Sound risk-based judgment and decision-making; thrive in fast-paced, evolving biotech; commitment to quality/compliance/patient safety
Compensation/Benefits:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
- A Summary of Benefits is available for applicants.
Application instructions:
- Olema doesn’t accept agency resumes; not responsible for fees related to unsolicited resumes.
Responsibilities:
- Define and drive a pragmatic, phase-appropriate, unified Quality strategy aligned with pipeline and corporate objectives
- Establish Quality governance, decision-making frameworks, and escalation pathways
- Lead and develop Quality leadership across GCP, GMP, and GPV; foster accountability
- Foster a culture of quality, integrity, and patient focus; act as escalation point for significant quality/compliance/patient safety risks
- Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains
- Set direction for scalable, integrated Quality Management framework across clinical through commercial stages
- Drive consistency in quality processes, risk management, and data integrity standards; establish quality metrics and reporting
- Ensure Quality approaches support oncology clinical trial execution; oversee clinical quality and CRO management
- Provide Quality input into CMC, validation, and supply chain readiness; oversee GMP Quality, including CMO/CDMO oversight and inspection preparedness
- Oversee pharmacovigilance quality framework; ensure PV systems and vendors are governed and inspection-ready; partner on benefit-risk evaluation
- Lead regulatory inspection approach (preparation and execution) and risk-based audit programs across GCP/GMP/GPV; mitigate quality/compliance risks
- Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing to embed quality; represent Quality in executive and external engagements
Qualifications:
- Advanced degree (PhD, PharmD, MS) in Life Sciences or related field
- Deep knowledge of FDA, EMA, ICH, and global GxP/pharmacovigilance (GPV) requirements
- Expertise across GCP, GMP, and GPV Quality; strong understanding of Quality systems, governance, and inspection readiness
- Working knowledge of oncology drug development
- 15+ years Quality experience in biotech/pharma; people management leadership experience
- Experience overseeing global vendors (CROs, CMOs, CDMOs, PV vendors)
- Demonstrated GCP/GMP/GPV experience; track record from clinical development through late-stage/commercial readiness
- Experience leading regulatory inspections and interacting with global health authorities; implementing/maintaining Quality systems and compliance frameworks
Attributes:
- Ability to lead/develop senior leaders; executive communication and influencing skills
- Sound risk-based judgment and decision-making; thrive in fast-paced, evolving biotech; commitment to quality/compliance/patient safety
Compensation/Benefits:
- Base pay range: $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
- A Summary of Benefits is available for applicants.
Application instructions:
- Olema doesn’t accept agency resumes; not responsible for fees related to unsolicited resumes.