Senior Quality Assurance Engineer Lead

i-Pharm GxP; Illinois; On-site; USD 140,000 - 190,000; Full time

Job summary

i-Pharm GxP is seeking a Senior Quality Assurance Engineer Lead to head the global QA Engineering team in support of GMP-compliant biopharma initiatives. This 12-month onsite role reports to the VP QA Operations and focuses on quality oversight across process life cycle.

Responsibilities include QbD, tech transfer, validation (process, cleaning, filter), CPV, APR, deviations and change control, CAPEX/OPEX projects, and site inspections.

Qualifications

• Extensive experience in pharmaceutical/biotech QA with strong GxP background.
• Proven ability to lead global QA teams and coordinate across functions.
• Solid knowledge of regulatory guidelines (FDA, EU, TGA, etc.).

Responsibilities

• Lead the global QA Engineering team to ensure GMP compliance.
• Oversee QA activities across life-cycle stages: QbD, tech transfer, validation, CPV, APR.
• Direct commissioning/qualification, IQ/OQ/PQ, and maintenance requirements.
• Manage deviations, change controls, and CAPEX/OPEX projects with QA oversight.
• Support dossiers, inspections, and collaboration across QA Operations, GRA, and R&D.

Skills

GxP compliance

QA leadership

FDA/EU knowledge

Process validation

Technology transfer

Education

Engineering degree

Advanced degree preferred

Job description

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.

Key Responsibilities

• 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.

Required Experience

• 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.

Preferred Technical Experience

• 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.