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.  You can view our latest corporate deck and other presentations https://ir.olema.com/. 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.  #LI-AD1 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. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. 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 https://olema.com/; our careers page is https://olema.com/careers/; our LinkedIn page is https://www.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. Offices: San Francisco, California, United States (Brannan / SF); San Francisco, California, United States (Owens / SF); Boston, Massachusetts, United States (Rogers / Boston);