Senior Director, GxP Vendor Management and Compliance - Redwood City - Revolution Medicines

    Revolution Medicines
    Revolution Medicines Redwood City

    1 week ago

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    Description

    Job Description:

    We are seeking a highly skilled Compliance Supplier Quality Lead to join our team at Revolution Medicines. This is a leadership role responsible for overseeing the compliance of GxP vendors providing regulated services and products to RevMed.

    This role will serve as the Compliance Supplier Quality Lead for RevMed GxP vendor management, ensuring compliance with global regulatory requirements, industry standards, and company policies related to clinical trials.

    • Design, develop, and implement a global compliance strategy to manage GxP vendors aligned with corporate objectives and global regulatory requirements.

    • Establish a risk-based process/framework to plan, select vendors, conduct audits, qualifications, and oversight based on business impact and regulatory requirements.

    • Work with RevMed GxP Quality Heads to oversee the development, implementation, and management of GxP vendors, quality systems procedures, and audits.

    • Serve as the Quality lead for Quality Agreements. Draft, review, and approve Technical Quality Agreement including negotiation of agreements with all major GxP vendors.

    • Compile and track quality and compliance metrics (KPI) for GxP vendors and report to management on a quarterly basis.

    • Lead and manage RevMed GxP audits program; develop audits schedule (annually) and conduct internal and external audits.

    • Conduct quality audits of GMP vendors (clinical and commercial) to ensure compliance with RevMed procedures, Quality Agreements, and global regulations.

    • Manage a team of GxP auditors (internal) and external contractors to support RevMed vendor management program.

    • Prepare supplier quality audit budget annually and present to quality management.

    • Support partner audits, due diligence activities, and regulatory inspections at RevMed including RevMed GxP Vendors, ensuring inspection readiness and timely resolution of findings.

    • Identify, assess, and mitigate GxP compliance risks including escalation of critical vendor quality events and performance to Sr. management.

    • Collaborate with PDM, Clinical Operations/Development, Regulatory Affairs, GPS, and other stakeholders to address GxP vendor quality events, ensure alignment on quality and compliance objectives, and drive continuous improvement.

    • Partner with PDM and Clinical Operations in selection of GMP and GCP vendors including managing the routine qualification activities and monitoring key KPI's.

    • Hire and manage a team of GCP and GMP auditors.

    • Build, mentor, and lead a high-performing team of auditors. Provide training and development opportunities to enhance team capabilities.

    • Foster a culture of quality, accountability, and collaboration within the team and across the organization.

    • Stay current with global regulations and provide guidance to quality professionals and cross-functional teams, and to senior management, as needed.

    Requirements:

    • Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).

    • Minimum of 15+ years of experience in the pharmaceutical or biotechnology industry, with at least 10 years' experience conducting supplier audits across clinical and commercial vendors.

    • Minimum of 5+ years' experience hosting/supporting regulatory inspections (e.g., FDA, EMA, PMDA) in support of BIMO/PAI including conducting mock inspections at GMP establishments.

    • Certified Quality Auditor, CQA (ASQ), ISO lead auditor or equivalent.

    • Proven track record and relevant industry experience in leading supplier quality responsibilities within a global quality organization.

    • Strong understanding and knowledge of global regulations (FDA, EU, ICH Q7), and other applicable regulatory guidelines.

    • Excellent leadership, communication, team building, and people skills, with the ability to influence stakeholders at all levels.

    • Analytical thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for quality audits, inspections, and vendor meetings.

    • Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

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