Director, GMP and Quality Systems Compliance
Listed on 2025-12-27
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Quality Assurance - QA/QC
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Healthcare
Director, GMP and Quality Systems Compliance
Join to apply for the Director, GMP and Quality Systems Compliance role at Olema Oncology.
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.
As the Director, GMP and Quality Systems Compliance, reporting to the Senior Director, Quality Assurance, you will lead and oversee compliance across Olema’s GMP and Quality Systems functions. You will establish procedural and system requirements for Supplier and Contract Service Provider Quality Management, maintain continuous inspection readiness across Olema’s clinical—and future commercial—network, develop and maintain a Regulatory Intelligence function, oversee internal audits and self‑assessments, and coordinate the execution of annual Quality System reviews, including Quality Management Review (QMR) and Annual Product Reviews following commercial launch.
This role is based in either Cambridge, MA or San Francisco, CA and requires up to 25% travel, including some international.
- Partner with regulated business functions to identify Suppliers and CSPs requiring quality and compliance oversight
- Establish appropriate assessment mechanisms, risk‑based controls, and monitoring and feedback loops to ensure compliant, effective oversight
- Serve as a resource for the conduct of audits and other assessments, both internally and externally
- Establish and maintain the infrastructure and processes required to prepare Olema and its business partners for inspections by U.S. and international regulatory authorities
- Utilize electronic systems, including Artificial Intelligence‑enabled tools, to support inspection readiness activities
- Deploy and maintain Inspection Management Software to ensure consistent and reliable inspection preparation and response
- Create and maintain a Regulatory Intelligence function focused on understanding inspectorate enforcement trends and providing insights that support accelerated product development
- Monitor inspectional status and compliance trends within the Olema Supplier and CSP network
- Apply Generative AI tools, where appropriate, to support the monitoring and interpretation of regulatory trends and inspection outcomes
- Develop strategic, minimally disruptive methods to identify internal compliance risks and opportunities related to quality, efficiency, and effectiveness
- Collaborate with internal partners to build commitment and alignment around the implementation of identified opportunities for improvement
- Provide guidance and direction to ensure Quality and regulated functions meet annual Quality System commitments in a timely manner as Olema advances toward commercial operations
- Lead and coordinate the annual Quality Management Review process
- Oversee the preparation and execution of Annual Product Quality Reviews upon commercial product launch
- Collaborate with Quality Systems to plan and deliver annual GxP topical training for relevant functions
- Deploy Inspection Management Software and ensure users receive appropriate training
- Use and train others in the application of Artificial Intelligence toolsets for Quality and Compliance operations
- Advise cross‑functional partners on the…
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