Job Details

Senior Director, GxP Vendor Management and Compliance

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Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. Our pipeline includes RAS(ON) Inhibitors and RAS Companion Inhibitors, aiming to improve treatment options for patients with mutations in the RAS pathway. As a team member, you'll work alongside top-quality professionals committed to advancing cancer treatment.

Opportunity

This leadership role oversees compliance of GxP vendors providing regulated services and products. You will serve as the Compliance Supplier Quality Lead, ensuring adherence to global regulatory standards, industry practices, and company policies related to clinical trials. Responsibilities include leading a QA team, providing strategic guidance, driving continuous improvement, and maintaining high-quality standards. You will report directly to the Vice President, Global Quality.

Key Responsibilities

1. Develop and implement a global compliance strategy for GxP vendors aligned with corporate and regulatory requirements.
2. Establish risk-based processes for vendor selection, audits, qualifications, and oversight.
3. Collaborate with GxP Quality Heads to manage quality systems, procedures, and audits.
4. Lead the development and negotiation of Quality Agreements with GxP vendors.
5. Track and report quality metrics (KPIs) to management quarterly.
6. Manage the GxP audit program, including scheduling and conducting audits.
7. Perform quality audits of GMP vendors to ensure compliance.
8. Manage internal and external GxP auditors and support vendor management programs.
9. Prepare and oversee the supplier quality audit budget.
10. Support partner audits, regulatory inspections, and ensure inspection readiness.
11. Identify and mitigate GxP compliance risks, escalating critical issues as needed.
12. Work with cross-functional teams to address vendor quality events and drive improvements.
13. Assist in selecting GMP and GCP vendors, managing qualification activities, and monitoring KPIs.
14. Build, mentor, and lead a team of auditors, fostering a culture of quality and accountability.
15. Stay updated on global regulations and provide guidance to teams and senior management.

Required Skills, Experience, and Education

• Advanced degree in life sciences, pharmacy, chemistry, or related field (PhD, MS preferred).
• 15+ years in pharma/biotech, with 10+ years conducting vendor audits.
• 5+ years supporting regulatory inspections (FDA, EMA, PMDA), including mock inspections.
• Certified Quality Auditor (CQA), ISO lead auditor, or equivalent.
• Proven leadership in supplier quality within a global organization.
• Strong knowledge of global regulations (FDA, EU, ICH Q7) and guidelines.
• Excellent leadership, communication, and stakeholder influence skills.
• Analytical mindset focused on continuous improvement; willingness to travel (~20%).

Preferred Skills

• Experience with auditing commercial GMP vendors (DS, SDD, DP, Packaging).
• Experience with regulatory inspections (host/SME).

The salary range is $236,000 to $295,000, depending on location and experience, with comprehensive benefits and incentives. Revolution Medicines is an equal opportunity employer committed to diversity and privacy protection.

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