Senior QA Manager, GMP GXP Auditing & Vendor Management

Revolution Medicines•Redwood City, CA

2d•$164,000 - $205,000•Hybrid

About The Position

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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Lead internal audit of systems and relative departments to GMP/GxP regulations, following up through CAPA implementation. Perform GxP internal and external audits to applicable regulations including completing audit reports and follow-up on corrective actions. Assure suppliers are GMP/GxP compliant. Understand working in a dynamic environment of developing new product and demonstrate capability to manage vendor management and auditing programs. Oversight of all aspects of GxP vendor / supplier program management to ensure compliance with GxP regulations and RevMed internal standards. Maintain the internal and external annual audit schedules. Demonstrate the ability to multi-task, prioritize work, and independently solve problems. Collaborate with vendors and internal teams to draft and complete Quality Agreements. Partner with cross-functional teams and represent Quality Vendor management at meetings. GxP vendor/supplier program management to ensure compliance with GxP regulations and RevMed internal standards. Perform Risk Assessments, Qualifications of vendors, and monitor suppliers/CMOs. Update SOPS. Create and implement tools to improve compliance, consistency, and efficiency for GMP/GxP auditing and vendor management. Provide support in preparation of anticipated regulatory inspections (including at contrated organizations) and partner with cross-functional teams. Maintain supplier management program, enduring requirements, plans, processes, metrics, and tracking systems for GxP suppliers are established and followed. Responsible for the qualification of GMP/GxP suppliers including performing audits, generation of audit reports, and follow-up on CAPA. Negotiate, draft, and manage Quality Agreements and/or contracts with suppliers while ensuring alignment with SOPs, 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. Update Veeva, track KPIs, and assure GxP audits completed on time.

Requirements

BA/BS degree in Biological Sciences, Chemistry, or related field and /or equivalent experience and education.
Minimum experience required: 10+ years of pharmaceutical/Biotech experience experience with a minimum of 5+ years GMP Auditing experience including having audited TMFs.
Familiar with GMP, GxP regulations in US and EU and ICH requirements.
ASQ Certified Quality Auditor or equivalent certifications.
Excellent leadership and people management /development skills.
Strong written and oral communication skills as well as organizational skills.
Ability to travel occasionally (up to 25%) to support audits and qualification activities.
Ability to navigate through rapid growth and adapt to rapid change.
Direct experience working with Quality System electronic databases.
Proficiency with Microsoft Office (Excel, Outlook, Powerpoint, Work) required.

Nice To Haves

Quality Vendor qualification and risk assessment experience.
Strategic thinking and project management skills.
Direct experience with handling and /or participating in regulatory body inspections.
Proven ability to develop presentations and analyze complex data.
Experience working with Veeva Quality System Platform.

Responsibilities

Lead internal audit of systems and relative departments to GMP/GxP regulations, following up through CAPA implementation.
Perform GxP internal and external audits to applicable regulations including completing audit reports and follow-up on corrective actions.
Assure suppliers are GMP/GxP compliant.
Understand working in a dynamic environment of developing new product and demonstrate capability to manage vendor management and auditing programs.
Oversight of all aspects of GxP vendor / supplier program management to ensure compliance with GxP regulations and RevMed internal standards.
Maintain the internal and external annual audit schedules.
Demonstrate the ability to multi-task, prioritize work, and independently solve problems.
Collaborate with vendors and internal teams to draft and complete Quality Agreements.
Partner with cross-functional teams and represent Quality Vendor management at meetings.
GxP vendor/supplier program management to ensure compliance with GxP regulations and RevMed internal standards.
Perform Risk Assessments, Qualifications of vendors, and monitor suppliers/CMOs.
Update SOPS.
Create and implement tools to improve compliance, consistency, and efficiency for GMP/GxP auditing and vendor management.
Provide support in preparation of anticipated regulatory inspections (including at contrated organizations) and partner with cross-functional teams.
Maintain supplier management program, enduring requirements, plans, processes, metrics, and tracking systems for GxP suppliers are established and followed.
Responsible for the qualification of GMP/GxP suppliers including performing audits, generation of audit reports, and follow-up on CAPA.
Negotiate, draft, and manage Quality Agreements and/or contracts with suppliers while ensuring alignment with SOPs, 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.
Update Veeva, track KPIs, and assure GxP audits completed on time.
Maintain the approved GxP supplier list.