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 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, including international.

Responsibilities

• Supplier / Contract Service Provider Quality Management: identify Suppliers and CSPs requiring quality and compliance oversight; establish assessment mechanisms, risk-based controls, and monitoring loops; serve as a resource for audits and assessments.
• Inspection Readiness and Compliance Infrastructure: build and maintain infrastructure and processes for regulatory inspections; leverage electronic systems and AI-enabled tools to support readiness; deploy Inspection Management Software for consistent preparation and response.
• Regulatory Intelligence and Monitoring: create and maintain Regulatory Intelligence to understand inspectorate trends and support accelerated product development; monitor compliance trends within the supplier network; apply Generative AI tools to support monitoring and interpretation of regulatory trends.
• Internal Compliance Risk Identification and Quality Improvement: develop minimally disruptive methods to identify internal compliance risks and opportunities; collaborate to implement improvements; ensure annual Quality System commitments are met as operations progress toward commercial.
• Annual Reviews and Quality System Leadership: lead the annual Quality Management Review; oversee Annual Product Quality Reviews upon commercial launch; plan and deliver annual GxP topical training.
• Additional Responsibilities: deploy and train users on Inspection Management Software; train others in AI toolsets for Quality and Compliance; advise on risk-appropriate deployment of GMP technologies; perform audits and supplier questionnaires; process SCARs and ECNs.

Qualifications

• Required: 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.
• Preferred: Pharmaceutical Auditor certification; oncology experience; people management or leadership experience; minimum 15 years in biopharmaceutical industry; minimum 10 years in Supplier Quality Management; experience with Oral Solid Dosage forms.
• Attributes: self-directed, able to manage competing priorities, risk-based thinker with strong collaboration and communication skills; comfortable adopting new technologies and tailoring them to quality needs; team-oriented and patient-focused.

Education

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

Additional Requirements

• Location: Cambridge, MA or San Francisco, CA; travel up to 25%, including international.