Vice President, Quality Assurance

Vice President, Quality Assurance

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. It's an exciting time to be part of Team Olema, with our transformation into a fully integrated oncology company well underway, top-line data from our lead program expected later this year, and our first potential commercial launch on the horizon.

Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity.

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. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC.

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day.

If you're ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what's beyond.

About the Role >>> Vice President, Quality Assurance

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 our either our San Francisco, CA or Boston, MA office and will require some travel as needed.

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership

• 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

Quality Systems & Governance

• 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

Clinical Quality (GCP)

• 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

Manufacturing & Commercial Readiness (GMP)

• 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

Pharmacovigilance Quality (GPV)

• 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

Inspection, Audit & Risk Management

• 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

Cross-Functional Leadership

• 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

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• 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

Experience

• 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

Attributes

• 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

The base pay range for this position is expected to be $315,000 - $340,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

Important Information >>>

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience