Director, GMP and Quality Systems Compliance

Olema Oncology•Boston, MA

3d•Onsite

About The Position

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 here. As the Director, GMP and Quality Systems Compliance, reporting to the Senior Director, Quality Assurance, you will hold responsibility for leading and overseeing compliance across Olema’s GMP and Quality Systems functions. In this role, you will establish the procedural and system requirements for Supplier and Contract Service Provider (CSP) 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 out of either our Cambridge, MA or San Francisco, CA office location and will require up to 25% travel, including some international.

Requirements

Bachelor's degree in biology or a related scientific field is required
Strong understanding of U.S., EU, California, and Rest-of-World (ROW) regulatory and compliance requirements
Demonstrated experience in Supplier Compliance and Inspection Management
Firm knowledge of GMPs and Quality Management Systems
Experience using Inspection Management Software
Minimum 15 years of experience in Biopharmaceutical industry
Minimum 10 Years of experience in Supplier Quality Management
Experience with Oral Solid Dosage forms is required

Nice To Haves

Pharmaceutical Auditor certification is highly preferred
Oncology experience is preferred
People management or leadership experience is desirable, particularly given the need to oversee contract resources and support future functional growth

Responsibilities

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 risk-appropriate and timely deployment of additional Quality and GMP technologies
Perform audits and execute Supplier or CSP questionnaires
Process Supplier Corrective Action Requests (SCARs) and External Change Notifications (ECNs)