Senior Quality Assurance Engineer Lead

Job Title: Senior Quality Assurance Engineer Lead

Contract: 12 months (extensions anticipated) | Onsite | Full-time | W2

We are supporting a global biotherapeutics leader on a major quality engineering mandate and are seeking an experienced CQV Engineering Quality Lead to lead the global QA Engineering team and ensure compliance with company standards and GMP regulatory guidelines. Reports to the VP QA Operations.

• Lead the global QA Engineering team to ensure compliance with company standards and GMP regulatory guidelines.
• Provide quality oversight of process life cycle activities, including QbD, technology transfer, validation (process, cleaning, filter), CPV, APR, and improvement projects.
• Oversee commissioning and qualification activities, including drawings, URS, and IQ/OQ/PQ, and maintenance requirements.
• Direct methods transfer and validation, including method transfer, method validation, stability, and leachables & extractables (L&E).
• Lead CAPEX/vendor qualification, including internal QA ENG PMO, equipment vendor qualification and oversight, and Industry 4.0 initiatives.
• Ensure development, implementation, and maintenance of guidelines, SOPs, and global engineering standards consistent with regulatory and industry requirements.
• Support GRA in generating dossiers for submission and assessment of HA requests, and support site inspections on CAPEX/OPEX projects.
• Perform QA oversight and act as SME in deviations and change control requests.
• Support Global Engineering on CAPEX and OPEX projects from Phase III through to commercial.
• Drive collaboration across Global Engineering, QA Operations, QA Sterility Assurance, GRA, and R&D.

• At least 15 years of experience in the pharmaceutical/biotech industry.
• University degree in engineering or a relevant scientific discipline (chemistry, biology, microbiology, etc.); advanced degree preferred.
• Extensive professional experience leading global teams.
• Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU, TGA, German, and other regulatory agency guidelines.
• Manufacturing experience within biologics.
• Direct experience with QA oversight of technology transfers, qualification, and validation.

• Direct experience with one or more of the following:
• Process life cycle and CPV/validation oversight
• Commissioning and qualification (IQ/OQ/PQ)
• Methods transfer, method validation, and L&E
• CAPEX/vendor qualification and Industry 4.0

If you have genuine QA engineering leadership experience on large GMP projects and are looking for your next role, we'd like to hear from you.