Vice President Quality Assurance

Olema Oncology•Boston, MA

3h•Onsite

About The Position

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond, with lead program palazestrant (OP-1250) for metastatic breast cancer and follow-on product candidate OP-3136, a potent KAT6 inhibitor. The company fosters a culture of support, motivation, and challenge, prioritizing people. The Vice President, Quality Assurance is a senior leader responsible for defining and leading Olema’s global Quality strategy, systems, and governance across the end-to-end product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader serves as the primary voice of Quality at the executive level, ensuring a phase-appropriate, risk-based approach to quality that reflects the critical needs of oncology drug development: patient safety, data integrity, and speed. Operating as an independent function, this leader will partner cross-functionally and lead through an established Quality leadership team across GCP, GMP, and GPV, aligning priorities, strengthening execution, and ensuring sustained inspection readiness as Olema advances toward late-stage development. This role is based out of either the San Francisco, CA or Boston, MA office and will require some travel as needed.

Requirements

Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS)
Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement
Expertise across GCP, GMP, and GPV Quality domains
Strong understanding of Quality systems, governance, and inspection readiness practices
Working knowledge of oncology drug development
Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility
Significant people management and leadership experience, including leading senior team members
Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors
Demonstrated experience across GCP, GMP, and GPV environments
Proven track record supporting programs from clinical development through late-stage or commercial readiness
Experience leading regulatory inspections and interacting with global health authorities
Experience implementing and maintaining Quality systems and compliance frameworks
Strong leadership capability with ability to lead through and develop senior leaders
Effective communicator with executive presence and influencing skills
Sound judgment and decision-making in complex, risk-based environments
Ability to operate effectively in a fast-paced, evolving biotech environment
Commitment to quality, compliance, and patient safety

Responsibilities

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, establishing clear governance, decision-making frameworks, and escalation pathways
Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear 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 the QA 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/CDMO oversight 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 Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization
Provide clear, actionable Quality perspectives to support business decisions
Represent Quality in executive discussions and external engagements as needed