Senior QA Manager, GMP GxP Auditing & Vendor Management

Revolution Medicines•Redwood City, CA

13d•Remote

About The Position

The Senior QA Manager leads GMP/GxP auditing and vendor management at Revolution Medicines. This role oversees internal and external audits, supplier qualifications and performance, and the supplier management program to ensure compliance with GxP regulations and company standards. The manager collaborates with vendors and cross-functional teams on quality agreements, audit follow-up, risk assessments, and inspection preparation. The position also maintains supplier records and schedules, tracks KPIs, and develops tools and communications to improve compliance, consistency, and efficiency. Occasional travel of up to 25% is required to conduct external audits.

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.
At least 5 years of GMP Lead Auditor experience.
At least 5 years of 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 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, prepare audit reports, and follow up on corrective actions.
Maintain internal and external audit schedules and the approved GxP supplier list.
Oversee the GxP vendor and supplier management program to ensure compliance with regulations and internal standards.
Collaborate with vendors and internal teams to draft and complete Quality Agreements.
Perform supplier risk assessments and qualifications, and monitor suppliers and CMOs.
Represent Quality Vendor Management at cross-functional meetings and lead meetings to align stakeholders, communicate, and resolve issues.
Create and implement tools to improve compliance, consistency, and efficiency in GMP/GxP auditing and vendor management.
Support preparation for anticipated regulatory inspections, including inspections at contracted organizations, and partner audits with cross-functional teams.
Establish and maintain requirements, plans, processes, metrics, and tracking systems for GxP suppliers, ensuring they are followed.
Qualify GMP suppliers, conduct audits, generate audit reports, and follow up with suppliers to address audit observations.
Negotiate, draft, and manage quality technical agreements and/or supplier contracts, ensuring alignment with internal, regulatory, and industry standards.
Escalate critical findings to responsible management and support immediate follow-up measures according to company procedures.
Lead supplier performance metrics to monitor system health, identify risks proactively, and mitigate compliance issues.
Prepare slides and presentations for reviews and stakeholder communications.
Update Veeva, track KPIs, and assure GxP audits.