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 GMP and Quality Systems. Establish procedural and system requirements for Supplier and Contract Service Provider Quality Management, maintain inspection readiness across the clinical and future commercial network, develop Regulatory Intelligence, oversee internal audits and self-assessments, and coordinate annual Quality System reviews including QMR and Annual Product Reviews after commercial launch. Based in Cambridge, MA or San Francisco, CA with up to 25% travel.

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 and feedback loops for compliant oversight
  • Serve as a resource for audits and other assessments, internally and externally

• Inspection Readiness and Compliance Infrastructure
  • Establish and maintain infrastructure and processes to prepare Olema and partners for inspections by U.S. and international regulators
  • Utilize electronic systems, including AI-enabled tools, to support inspection readiness activities
  • Deploy and maintain Inspection Management Software for consistent inspection preparation and response

• Regulatory Intelligence and Monitoring
  • Create and maintain Regulatory Intelligence focusing on inspectorate enforcement trends to support accelerated product development
  • Monitor inspection status and compliance trends within the 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 implementing opportunities for improvement
  • Guide Quality and regulated functions to meet annual Quality System commitments as Olema approaches 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

• Bachelor's degree in biology or a related scientific field
• 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
• Pharmaceutical Auditor certification is highly preferred
• Oncology experience is preferred
• People management or leadership experience is desirable for overseeing contract resources and growth
• Self-directed, able to set and manage priorities
• Adaptable to rapid organizational change and evolving processes
• Risk-based approach to quality and compliance with focus on business and patient impact
• Strong cross-functional partnership, collaboration, and communication skills
• Comfort with adopting and tailoring new technologies to Quality and Compliance needs
• Team-oriented with a focus on delivering meaningful impact
• Passionate about contributing to patient-focused outcomes