Director, GMP and Quality Systems Compliance

Role Summary

Director, GMP and Quality Systems Compliance, reporting to the Senior Director, Quality Assurance, responsible for leading and overseeing compliance across Olema’s GMP and Quality Systems functions. Establish 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 in Cambridge, MA or San Francisco, CA and requires up to 25% travel, including some international.

Responsibilities

• Supplier / Contract Service Provider Quality Management: Partner with regulated business functions to identify Suppliers and CSPs requiring quality and compliance oversight; establish assessment mechanisms, risk-based controls, and monitoring/feedback loops to ensure compliant oversight; serve as a resource for audits and other assessments, both internal and external.
• Inspection Readiness and Compliance Infrastructure: Establish and maintain the infrastructure and processes to prepare Olema and its business partners for inspections by U.S. and international regulatory authorities; utilize electronic systems, including AI-enabled tools, to support inspection readiness; deploy and maintain Inspection Management Software for consistent inspection preparation and response.
• Regulatory Intelligence and Monitoring: Create and maintain a Regulatory Intelligence function focused on inspectorate enforcement trends and insights that support accelerated product development; monitor inspectional status and compliance trends within the Olema Supplier and CSP network; apply Generative AI tools to support monitoring and interpretation of regulatory trends and outcomes.
• Internal Compliance Risk Identification and Quality Improvement: Develop minimally disruptive methods to identify internal compliance risks and opportunities related to quality, efficiency, and effectiveness; collaborate with internal partners to build commitment around implementation of opportunities; provide guidance to ensure Quality and regulated functions meet annual Quality System commitments as Olema moves toward commercial operations.
• Annual Reviews and Quality System Leadership: Lead and coordinate the annual Quality Management Review process; oversee 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 train users; use and train others in AI toolsets for Quality and Compliance operations; advise cross-functional partners on risk-appropriate 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).

Qualifications

• 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 the 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 to oversee contract resources and support future growth.
• Attributes: Self-directed with ability to set and manage priorities; adaptable to a rapidly changing organization; applies a risk-based approach balancing business needs and patient impact; strong cross-functional partnership, collaboration, and communication skills; comfortable adopting new technologies and tailoring them to Olema’s Quality and Compliance needs; team-oriented and focused on delivering meaningful impact; passionate about patient-focused outcomes.

Skills

• Supplier quality management and inspection management
• Regulatory intelligence and monitoring
• Inspection readiness and audit facilitation
• Quality systems leadership and annual reviews (QMR, APQR)
• Experience with AI tools and electronic quality systems

Education

• Bachelor's degree in biology or a related scientific field (required)