Senior QA Manager, GMP GxP Auditing & Vendor Management

The Opportunity:

• Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions.

• Maintain the internal/external audit schedules.

• Assure GMP/GxP compliance with suppliers.

• Oversight of all aspects of GxP vendor / supplier program management to ensure compliance with GxP regulations and RevMed internal standards.

• Demonstrate the ability to multi-tack. Prioritize work and independently solve problems.

• Collaborate with vendors and internal teams to draft and complete Quality Agreements.

• Perform Risk Assessments, qualifications, and monitor Suppliers/CMOs.

• Collaborate with cross-functional teams and represent Quality Vendor Management at meetings.

• Create and implement any tools to improve compliance, consistency, and efficiency for GMP/GXP auditing and Vendor management.

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

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

• 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 technical agreements (QTA) and/or contracts with suppliers, ensuring alignment with internal standards, regulations, and industry standards.

• Lead meetings for alignment, communication, and resolution of issues.

• 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.

• Generate slides and presentations for reviews and communication to stakeholders.

• Update Veeva, track KPIs, assure GxP audits.

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

Required Skills, Experience and Education:

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

• Minimum experience required 8+ years of pharmaceutical/Biotech experience with a minimum of 5+ years’ GMP Lead Auditor experience.

• 5 years of QTA and Supplier Quality Management experience.

• ASQ Certified Quality Auditor or equivalent certifications.

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

• Direct experience working with Quality System electronic databases.

• Strong written and oral communication skills as well as negotiation skills.

• Ability to travel occasionally (up to 25%) to perform external audits.

• Flexible, and an ability to navigate through rapid growth and adapt to rapid change.

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

Preferred Skills:

• 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 analyzing complex data.

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