Senior QA Manager, GMP GxP Auditing & Vendor Management

Revolution Medicines•Redwood City, CA

17d•$164,000 - $205,000•Remote

About The Position

The Senior QA Manager leads GxP internal and external audits, prepares audit reports, and follows up on corrective actions. The role maintains internal and external audit schedules and the approved GxP supplier list, and assures supplier compliance with GMP/GxP regulations and Revolution Medicines’ internal standards. The position oversees the GxP vendor and supplier management program, including supplier qualification, risk assessments, monitoring of suppliers and CMOs, and management of quality technical agreements. The manager collaborates with vendors and cross-functional teams, leads meetings to align stakeholders and resolve issues, escalates critical findings, and supports follow-up measures. The role also supports regulatory inspection preparation, tracks KPIs and supplier performance metrics, maintains program processes and tracking systems, and develops tools to improve compliance, consistency, and efficiency. The position generates presentations for stakeholder reviews and updates Veeva.

Requirements

Bachelor’s degree in Biological Sciences, Chemistry, or a related field, and/or equivalent experience and education.
At least 8 years of pharmaceutical or biotech experience, including at least 5 years of GMP Lead Auditor experience.
At least 5 years of Quality Technical Agreement (QTA) and Supplier Quality Management experience.
ASQ Certified Quality Auditor or equivalent certification.
Excellent leadership and people management/development skills.
Direct experience working with electronic Quality System databases.
Strong written and oral communication and negotiation skills.
Ability to travel occasionally, up to 25%, to perform external audits.
Flexibility and ability to adapt to rapid growth and change.
Proficiency with Microsoft Office, including Excel, Outlook, PowerPoint, and Word.

Nice To Haves

Direct experience writing and negotiating Quality Agreements with suppliers and partners.
Vendor qualification and risk assessment experience.
Strategic thinking and project management skills.
Extensive experience leading audits, evaluating CAPA, and developing presentations that analyze complex data.

Responsibilities

Lead GxP internal and external audits, complete audit reports, and follow up on corrective actions.
Maintain internal and external audit schedules and the approved GxP supplier list.
Assure GMP/GxP compliance among suppliers and oversee the GxP vendor and supplier management program.
Perform supplier risk assessments and qualifications, and monitor suppliers and CMOs.
Collaborate with vendors and internal teams to draft and complete Quality Agreements.
Qualify GMP suppliers, conduct audits, prepare audit reports, and follow up with suppliers on audit observations.
Negotiate, draft, and manage quality technical agreements and/or supplier contracts to align with internal, regulatory, and industry standards.
Represent Quality Vendor Management in cross-functional meetings and lead meetings to align stakeholders, communicate, and resolve issues.
Escalate critical findings to responsible management and support immediate follow-up measures under company procedures.
Lead supplier performance metrics to monitor systems, identify risk proactively, and mitigate compliance issues.
Maintain the supplier management program, including requirements, plans, processes, metrics, and tracking systems for GxP suppliers.
Support preparation for anticipated regulatory inspections, including inspections at contracted organizations, and partner audits with cross-functional teams.
Create and implement tools to improve compliance, consistency, and efficiency in GMP/GxP auditing and vendor management.
Generate slides and presentations for reviews and stakeholder communications.
Update Veeva, track KPIs, and assure GxP audits.