Global QA Engineering Lead, GMP & Validation

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

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.