Senior QA Manager, GMP GxP Auditing & Vendor Management

About the role

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-task. 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.

Responsibilities

• 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.

Pay

Base Pay Salary Range $164,000 - $205,000 USD