Vice President Quality Assurance
Olema Oncology
August 07, 2026
Remote friendly (Boston, MA)
United States
Operations
Vice President, Quality Assurance (Quality)
Responsibilities:
- Define and drive a pragmatic, phase-appropriate, unified global Quality strategy across the product lifecycle.
- Establish governance, decision-making frameworks, and escalation pathways; lead and develop GCP/GMP/GPV Quality leadership.
- Act as escalation point for significant quality, compliance, and patient safety risks; ensure inspection readiness.
- Set direction for a scalable Quality Management framework (clinical through commercial).
- Drive consistency in quality processes, risk management, and data integrity standards; define quality metrics and reporting.
- Oversee clinical Quality and CRO management (GCP) to ensure patient safety and data integrity.
- Oversee GMP Quality, including appropriate CMO/CDMO oversight, and provide Quality input into CMC/validation/supply chain readiness.
- Oversee pharmacovigilance Quality (GPV), ensuring compliance, data integrity, and safety surveillance; govern PV systems/vendors.
- Lead regulatory inspections and risk-based audits across GCP/GMP/GPV.
- Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing to embed Quality; represent Quality externally as needed.
Qualifications:
- PhD, PharmD, or MS in Life Sciences or related field.
- Deep knowledge of FDA/EMA/ICH and global GxP and GPV regulatory requirements; expertise across GCP, GMP, and GPV.
- 15+ years Quality experience in biotech/pharma with increasing scope.
- People management/leadership experience.
- Experience overseeing global CRO/CMO/CDMO/PV vendor networks.
- Proven experience from clinical development through late-stage/commercial readiness.
- Experience leading regulatory inspections with global health authorities.
Skills/Attributes:
- Executive communication/influencing; strong judgment in risk-based environments; ability to operate in a fast-paced, evolving biotech.
Base Pay & Benefits (explicit):
- $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- Olema doesn’t accept agency resumes.
Responsibilities:
- Define and drive a pragmatic, phase-appropriate, unified global Quality strategy across the product lifecycle.
- Establish governance, decision-making frameworks, and escalation pathways; lead and develop GCP/GMP/GPV Quality leadership.
- Act as escalation point for significant quality, compliance, and patient safety risks; ensure inspection readiness.
- Set direction for a scalable Quality Management framework (clinical through commercial).
- Drive consistency in quality processes, risk management, and data integrity standards; define quality metrics and reporting.
- Oversee clinical Quality and CRO management (GCP) to ensure patient safety and data integrity.
- Oversee GMP Quality, including appropriate CMO/CDMO oversight, and provide Quality input into CMC/validation/supply chain readiness.
- Oversee pharmacovigilance Quality (GPV), ensuring compliance, data integrity, and safety surveillance; govern PV systems/vendors.
- Lead regulatory inspections and risk-based audits across GCP/GMP/GPV.
- Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing to embed Quality; represent Quality externally as needed.
Qualifications:
- PhD, PharmD, or MS in Life Sciences or related field.
- Deep knowledge of FDA/EMA/ICH and global GxP and GPV regulatory requirements; expertise across GCP, GMP, and GPV.
- 15+ years Quality experience in biotech/pharma with increasing scope.
- People management/leadership experience.
- Experience overseeing global CRO/CMO/CDMO/PV vendor networks.
- Proven experience from clinical development through late-stage/commercial readiness.
- Experience leading regulatory inspections with global health authorities.
Skills/Attributes:
- Executive communication/influencing; strong judgment in risk-based environments; ability to operate in a fast-paced, evolving biotech.
Base Pay & Benefits (explicit):
- $315,000–$340,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- Olema doesn’t accept agency resumes.