Senior QA Manager, GMP GXP Auditing & Vendor Management

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.

• Maintain the approved GxP supplier list.

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+ 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.

Preferred Skills:

• 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. 

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