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 transfor mation into a fully integrated oncology company well underway , t op-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 c