Overview In this role you lead the Quality Assurance function for West Laboratories, covering mechanical, biological, and analytical testing. You ensure QA oversight of lab activities, data integrity, and documentation to meet regulatory and customer expectations. You will also manage the global Lab QMS across labs in the Americas, Europe, and Asia, driving compliance and continuous improvement. You'll partner with operations and serve as the QA representative during audits and inspections. This position offers a chance to shape quality across a global lab network and support patient-centric outcomes.
Compensation / Benefits- relocation assistance
- benefit programs
Responsibilities- Lead QA oversight for West Laboratories' testing activities, documentation, and audits
- Provide QA review and approval of lab documents (protocols, reports, methods, specs, validation/verification, CAPAs, change controls, SOPs)
- Ensure data integrity per ALCOA+ and related controls across laboratory systems
- Investigate laboratory deviations, OOS/OOT, atypical results, contamination events, and documentation discrepancies
- Maintain inspection readiness for audits and regulatory inspections; represent QA in audits and discussions
- Collaborate with Laboratory Operations to maintain compliant equipment qualification, calibration, and system controls
- Support method qualification, validation, transfer, and lifecycle management from QA perspective
- Monitor quality metrics (deviations, CAPA effectiveness, audit findings, turn-around times, customer complaints) and drive improvements
- Lead and develop QA personnel; manage risk controls and cross-functional collaboration to support growth
- Escalate significant risks to leadership and ensure timely CAPA closure
- Ensure compliance with cGMP, GLP, ISO, USP/EP/JP, ICH, FDA, and customer quality agreements
- Support customer quality agreements, regulatory submissions, and quality inquiries as needed
- Maintain readiness for internal and external audits and certifications
- Oversee cross-functional risk assessment and continuous improvement initiatives across West Lab Services
Key requirements- 10+ years' experience in QA/Quality Control or regulated laboratory operations
- Experience supporting pharmaceutical/biotech/medical device or life sciences lab operations
- Strong knowledge of cGMP, GLP (where applicable), ISO standards, FDA regulations, GMP compendial requirements (USP/EP/JP), ICH guidance
- Demonstrated experience with investigations, OOS/OOT, deviations, CAPA, change control, and data integrity
- Experience leading multinational teams or quality professionals in regulated environments
- Experience hosting customer audits and regulatory inspections (Health Authority, Notified Bodies)
- Strong written and verbal communication skills with customers, auditors, lab staff, and senior leadership
- leadership
- collaboration
- effective communication
- ALCOA+ data integrity
- CAPA and change control
- QMS management (global scope)
