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 Olema’s 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 up to 25% travel, including some international.

Responsibilities

• Supplier / Contract Service Provider Quality Management: Partner with regulated business functions to identify Suppliers and CSPs needing quality and compliance oversight; establish assessment mechanisms, risk-based controls, and monitoring to ensure compliant oversight; serve as a resource for audits and assessments.
• 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 readiness; deploy and maintain Inspection Management Software for consistent inspection preparation and response.
• Regulatory Intelligence and Monitoring: Create and maintain Regulatory Intelligence to understand inspectorate enforcement trends and provide insights supporting accelerated product development; monitor inspectional status and compliance trends within the supplier network; apply Generative AI tools to monitor and interpret regulatory trends and inspection outcomes.
• Internal Compliance Risk Identification and Quality Improvement: Develop minimally disruptive methods to identify internal compliance risks and opportunities; collaborate with internal partners to implement opportunities; provide guidance to meet annual Quality System commitments as operations scale toward commercialization.
• Annual Reviews and Quality System Leadership: Lead and coordinate the annual Quality Management Review; oversee preparation and execution of Annual Product Quality Reviews upon commercial launch; collaborate to plan and deliver annual GxP training for relevant functions.
• Additional Responsibilities: Deploy Inspection Management Software and train users; apply AI toolsets for Quality and Compliance operations; advise on deployment of additional Quality and GMP technologies; perform audits and supplier questionnaires; process 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 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 in Supplier Quality Management
• Experience with Oral Solid Dosage forms; Pharmaceutical Auditor certification highly preferred; Oncology experience preferred
• People management or leadership experience desirable, especially for overseeing contract resources and future growth
• Self-directed, able to set and manage priorities; adaptable to a rapidly changing organization
• Risk-based approach to quality and compliance with strong attention to business and patient impact
• Strong cross-functional partnership, collaboration, and communication skills; comfortable adopting new technologies
• Team-oriented with a focus on delivering meaningful impact

Education

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

Skills

• GMP and Quality Management Systems expertise
• Supplier Quality Management and Inspection Management
• Regulatory Intelligence and monitoring, including AI tool applicability
• Quality System audits, QMR, Annual Product Reviews
• Training and change management in GxP environments

Additional Requirements

• Travel up to 25% including some international travel