Senior QA Manager, GxP Supplier Management Program

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity: 

• Oversight of all aspects of GxP (GMP, GCP, GLP) supplier program management to ensure compliance with GxP regulations and RevMed internal standards.

• Maintain supplier management program, ensuring requirements, plans, processes, metrics and tracking system for GxP suppliers are established and followed.

• Oversee the GxP external audit program, including auditor selection, result monitoring, and corrective action follow-up. Ensure GxP audits are performed using qualified auditors.

• Maintain the approved GxP supplier list and the annual audit schedules.

• Participate in GxP supplier selection with functional SMEs to ensure supplier compliance with regulations and internal RevMed standards.

• Foster cross-functional collaboration to execute ongoing risk assessments of suppliers to ensure accurate risk classification and management of suppliers.

• Responsible for qualifications of GMP suppliers including performing audits, generation of audit reports, and follow- up with suppliers for addressing observations from audits.

• Negotiate, draft, and manage quality agreements and/or contracts with suppliers, ensuring alignment with internal standards, regulations, and industry standards.

• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to RevMed procedures.

• Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk and mitigate compliance issues.

• Provide support preparation of anticipated regulatory inspections (PAI, BIMO including those at contracted organizations), and partner audits with cross-functional teams.

Required Skills, Experience and Education:

• BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.

• Minimum experience required: 10-15 years of pharmaceutical/Biotech experience with a minimum of 5+ years’ Supplier Quality Management and Auditing Experience.

• ASQ Certified Quality Auditor or equivalent certifications

• Excellent leadership and people management/development skills are required.

• Direct experience working with Veeva QualitySuite electronic platforms.

• Strong written and oral communication skills as well as organizational skills

• Ability to travel occasionally (up to 25%) to support supplier qualification activities.

• Ability to navigate through rapid growth and adapt to rapid change.

• Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required.

Preferred Skills:

• Strategic thinking and project management skills.

• Proven ability to conduct investigations, audits and develop presentations analyzing complex data.

• Direct experience with handling and/or participating in regulatory body inspections.

The base salary range for this full-time position is $158,000 to $198,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected].

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