Olema Oncology
Vice President Quality Assurance
Boston, Massachusetts · Exec
Sponsorship not specifiedDetected 20 days ago
GCPProduct ManagementSupply ChainClinical TrialsGMPFDA RegulatoryPharmacovigilanceLeadershipAdaptabilityGxP
About the role
- Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond.
- OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients.
- Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape - particularly in combination with palazestrant.
Responsibilities
- Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema's pipeline and corporate objectives
- Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability
- Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization
- Ensure Quality approaches appropriately support the execution of oncology clinical trials
- Partner with Clinical and Regulatory to support inspection-ready programs and submissions
- Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization
- Lead the Company's approach to regulatory inspections, including preparation and execution
- Drive proactive identification and mitigation of quality and compliance risks
- Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization
- Provide clear, actionable Quality perspectives to support business decisions
Requirements
- Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS)
- Strong understanding of Quality systems, governance, and inspection readiness practices
Compensation
- The base pay range for this position is expected to be
Benefits
- Partner cross-functionally to support ongoing evaluation of benefit-risk
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