Director, GMP and Quality Systems Compliance

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. 

Your work will primarily encompass: 

Supplier / Contract Service Provider Quality Management

• 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

 Inspection Readiness and Compliance Infrastructure

• 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 

Regulatory Intelligence and Monitoring

• 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

Internal Compliance Risk Identification and Quality Improvement

• 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

Annual Reviews and Quality System Leadership

• 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

Additional Responsibilities

• 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)

Ideal Candidate Profile >>>  

A nimble, curious learner with a solid understanding of compliance requirements and the ability to balance risk-based decision-making with business and patient needs. A team-oriented individual with strong work ethic, optimism, and commitment to meaningful contributions. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.  

Knowledge: 

• 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 

Experience: 

• 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  
• 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 

Attributes: 

• Self-directed and capable of independently setting and managing priorities
• Able to adapt to a rapidly changing organization characterized by historical ambiguity and evolving process definition
• Applies a risk-based approach to quality and compliance, with strong appreciation for both business needs and patient impact
• Demonstrates strong cross-functional partnership, collaboration, and communication skills
• Comfortable adopting new technologies and tailoring them to Olema’s Quality and Compliance needs
• Team-oriented, focused on collective success and delivering meaningful impact
• Passionate about meaningful work and contributing to patient-focused outcomes

The base pay range for this position is expected to be $225,000 - $240,000 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. 

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