Director, Lab QA – Hybrid Global QMS Leader

West Pharmaceutical Services, Inc; Exton (PA); On-site; USD 160,000 - 230,000; Full time

Job summary

West Pharmaceutical Services, Inc. is seeking a Director, Lab Quality Assurance in Exton, PA, a hybrid role with relocation support.

The position leads QA for the laboratory services organization across the Americas, Europe, and Asia, ensuring compliance with cGMP, GLP, ISO standards, and regulatory expectations while driving continual improvement and patient safety. The role requires 10+ years in QA/regulated labs, strong data integrity and audit readiness, and leadership of multinational

Qualifications

• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, Quality, or related scientific discipline.
• 10+ years experience in Quality Assurance, Quality Control, Laboratory Quality, Analytical Development, Microbiology, or regulated laboratory operations.
• Experience hosting customer audits and Health Authority, and Notified Body regulatory inspections.
• Strong understanding of cGMP, GLP where applicable, ISO standards, FDA regulations, USP/EP/JP compendial requirements, ICH guidance, and laboratory quality systems.

Responsibilities

• Lead the Quality Assurance function supporting West Laboratories, including data review, final release, Quality Systems, and audits.
• Provide QA oversight for laboratory testing activities, including sample receipt, data review, report generation, and release of customer deliverables.
• Ensure compliance with applicable requirements such as cGMP, GLP where applicable, ISO standards, USP, EP, JP, ICH guidance, FDA expectations, customer quality agreements, and internal West procedures.
• Oversee QA review and approval of laboratory documentation, including protocols, reports, test methods, specifications, validation/verification records, CAPAs, change controls, SOPs, and quality records.
• Maintain inspection readiness for customer audits, regulatory inspections, internal audits, and external certification assessments.

Education

Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, Quality, or related scientific discipline

Job description

West Pharmaceutical Services, Inc. is seeking a Director, Lab Quality Assurance in Exton, PA, a hybrid role with relocation support.

The position leads QA for the laboratory services organization across the Americas, Europe, and Asia, ensuring compliance with cGMP, GLP, ISO standards, and regulatory expectations while driving continual improvement and patient safety. The role requires 10+ years in QA/regulated labs, strong data integrity and audit readiness, and leadership of multinational