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 inspection readiness across the clinical and future commercial network, develop and maintain Regulatory Intelligence, oversee internal audits and self-assessments, and coordinate 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 with travel up to 25%, including international.

Responsibilities

• Partner with regulated business functions to identify Suppliers and CSPs requiring quality and compliance oversight
• Establish assessment mechanisms, risk-based controls, and monitoring to ensure compliant oversight
• Serve as a resource for audits and other assessments, internally and externally
• Establish and maintain infrastructure and processes to prepare 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 to ensure consistent inspection preparation and response
• Create and maintain Regulatory Intelligence focused on inspectorate enforcement trends and accelerated product development insights
• Monitor inspection status and compliance trends within the supplier and CSP network
• Apply Generative AI tools to monitor and interpret regulatory trends and inspection outcomes
• Identify internal compliance risks and opportunities related to quality, efficiency, and effectiveness
• Collaborate with internal partners to implement opportunities for improvement
• Provide guidance to ensure Quality and regulated functions meet annual Quality System commitments
• Lead and coordinate the annual Quality Management Review process
• Oversee preparation and execution of Annual Product Quality Reviews upon commercial product launch
• Plan and deliver annual GxP topical training for relevant functions
• Deploy Inspection Management Software and train users
• Train others in applying AI toolsets for Quality and Compliance operations
• Advise cross-functional partners on risk-appropriate deployment of Quality and GMP technologies
• Perform audits and execute Supplier or CSP questionnaires
• Process Supplier Corrective Action Requests (SCARs) and External Change Notifications (ECNs)

Qualifications

• Required: Bachelor's degree in biology or a related scientific field
• Required: Strong understanding of U.S., EU, California, and Rest-of-World regulatory and compliance requirements
• Required: Demonstrated experience in Supplier Compliance and Inspection Management
• Required: Firm knowledge of GMPs and Quality Management Systems
• Required: Experience using Inspection Management Software
• Required: Minimum 15 years of experience in Biopharmaceutical industry
• Required: Minimum 10 years of experience in Supplier Quality Management
• Required: Experience with Oral Solid Dosage forms
• Required: Oncology experience preferred
• Required: People management or leadership experience desirable
• Preferred: Pharmaceutical Auditor certification

Education

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

Additional Requirements

• Travel up to 25%, including some international