Dir, Quality Assurance

Description

This hybrid position is located in Exton, PA and open for relocation assistance for those who live outside the Exton area and are willing to relocate. At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O.

West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

This hybrid position is located in Exton, PA and open for relocation assistance for those who live outside the Exton area and are willing to relocate. At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O.

West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

Job Summary In this role, you will be responsible for leading and maintaining the Quality Assurance function supporting West’s laboratory services organization, includingmechanical, biological testing,and analytical testingoperations. This position provides leadership for QA oversight of laboratory operations and ensures that laboratory activities, quality systems, data integrity practices, testing documentation, investigations, and customer deliverables comply with applicable regulatory requirements, industry standards, customer expectations, and West quality policies.

Also, oversee the Global QMS, as the overall Lab QMS Lead, across the network of laboratories for West. The scope includes QMS for Labs facilities located in the Americas, Europe, and Asia.

Essential Duties And 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.
• Ensure laboratory data integrity principles are effectively implemented, including ALCOA+, audit trails, electronic records, electronic signatures, computerized system controls, and appropriate data review practices.
• Lead or oversee investigations for laboratory deviations, OOS/OOT results, atypical results, invalid assays, contamination events, method execution issues, and documentation discrepancies.
• Ensure CAPAs are scientifically justified, risk-based, effective, and completed within required timelines.
• Maintain inspection readiness for customer audits, regulatory inspections, internal audits, and external certification assessments.
• Serve as a QA representative during customer audits, regulatory inspections, and quality discussions related to West Lab Services.
• Partner with Laboratory Operations to ensure equipment qualification, calibration, maintenance, cleaning, and computerized laboratory systems remain in a compliant state.
• Support and or oversight for method qualification, validation, verification, transfer, and lifecycle management activities from a QA perspective.
• Monitor quality metrics and trends for laboratory operations, including deviations, CAPA effectiveness, right-first-time documentation, audit observations, turnaround time impacts, and…