Vice President Quality Assurance

Vice President Quality Assurance

Boston, Massachusetts

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.

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. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.