Vice President Quality Assurance

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.

Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond.

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of either our San Francisco, CA or Boston, MA office and will require some travel as needed.

• Define and drive a pragmatic, phase-appropriate and unified
  
  Quality strategy aligned with Olema’s pipeline and corporate objectives
• Serve as the senior Quality leader, establishingclear governance, decision-making frameworks, and escalation pathways
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong executionandmaintainingclear accountability
• Foster a culture of quality, integrity, and patient focus across the organization
• Act as escalation point for significant quality, compliance, and patient safety risks
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains

• Set expectations and direction for a scalable, integrated, and sustainable
  
  Quality Management framework spanning clinical through commercial stages
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across theQA function
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making

• Ensure Quality approaches appropriately support the execution of oncology clinical trials
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity
• 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
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMOoversight and inspection preparedness
• Provide Quality input into CMC, validation, and supply chain readiness activities

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance
• Ensure PV systems and vendors are appropriately governed and inspection-ready
• Partner cross-functionally to support ongoing evaluation of benefit-risk

• Lead the Company’s approach to regulatory inspections, including preparation and execution
• Ensure risk-based audit programs across GCP, GMP, and GPV
• Drive proactive identification and mitigation of quality and compliance risks

• Partner with Executive…