Dir, Quality Assurance

This hybrid position is located in Exton, PA and offers relocation assistance for those who live outside the area and are willing to relocate.

About the Role

At West, we’re a dedicated team connected by a purpose to improve patient lives, a mission that has been central to our company for more than a century. Our story began with Herman O. West solving the challenge of supplying penicillin in mass quantities during World War II. Today, we deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily. We foster an inclusive community of professionals with opportunities for lifelong learning, growth, and development. Supported by comprehensive benefit programs, we empower the physical, mental, emotional, and financial health of our team members and their families. We also give back to communities in need and are committed to sustainability efforts for a healthier environment and planet.

In this role, you will lead and maintain the Quality Assurance function supporting West’s laboratory services organization, including mechanical, biological testing, and analytical testing operations. This position provides leadership for QA oversight of laboratory operations, ensuring compliance with applicable regulatory requirements, industry standards, customer expectations, and West quality policies. You will also oversee the Global Quality Management System (QMS) as the Lab QMS Lead across West’s network of laboratories in the Americas, Europe, and Asia.

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 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 oversee 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 customer complaint trends.
• Drive continuous improvement initiatives to enhance laboratory compliance, documentation quality, testing reliability, cycle time, and customer satisfaction.
• Support customer quality agreements, statements of work, technical protocols, regulatory submissions, and responses to customer quality inquiries as needed.
• Provide leadership, coaching, development, and performance management for QA personnel supporting laboratory services.
• Collaborate with cross-functional teams to identify quality risks, implement risk controls, and support business growth within West Lab Services.
• Escalate significant quality, compliance, data integrity, or customer-impacting risks to appropriate leadership.
• Perform other duties as assigned.

This role supports QA oversight across laboratory services located in North America, Europe, and Asia for testing such as:

• Biological testing
• Analytical testing
• Quality systems
• Data integrity
• Equipment and computerized system compliance

Requirements

• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, Quality, or a related scientific discipline (or equivalent experience).
• 10+ years of experience in Quality Assurance, Quality Control, Laboratory Quality, Analytical Development, Microbiology, or regulated laboratory operations.
• Experience supporting laboratory operations in a pharmaceutical, biotechnology, medical device, contract testing, or life sciences environment.
• Strong understanding of cGMP, GLP (where applicable), ISO standards, FDA regulations, USP/EP/JP compendial requirements, ICH guidance, and laboratory quality systems.
• Demonstrated experience with laboratory investigations, OOS/OOT management, deviations, CAPA, change control, audit readiness, and data integrity.
• Experience leading multinational teams or managing quality professionals in a regulated environment.
• Experience hosting customer audits and Health Authority/Notified Body regulatory inspections.
• Strong written and verbal communication skills, including the ability to interact effectively with customers, auditors, laboratory personnel, and senior leadership.

Preferred Skills

• Ensure compliance and quality performance across laboratory operations, including CCI, microbiology/biological, and analytical chemistry testing.
• Maintain an effective laboratory Quality Management System through timely management of deviations, CAPAs, change controls, and audit actions.
• Ensure data integrity and compliance with ALCOA+ principles in laboratory documentation, computerized systems, and quality records.
• Lead scientifically sound investigations, root cause analysis, and effective CAPA implementation for laboratory quality events.
• Maintain continuous audit and inspection readiness for internal, customer, and regulatory assessments.
• Ensure compliance with applicable regulatory, compendial, and industry standards, including ISO 9001, ISO 15378, ISO 17025, and GMP laboratory controls.
• Partner cross-functionally to support customer quality, risk-based decision-making, and continuous improvement initiatives.
• Lead and develop team capability while ensuring adherence to company safety and quality policies.

Travel Requirements

Up to 10% travel, approximately 26 business days per year.

Physical Requirements

Sedentary work—exerting up to 10 lbs/4 kg of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. The position operates in a professional office environment and may require standing or sitting for extended periods. Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines is required.

Additional Requirements

• Able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction, and adhere to procedures.
• Strong organizational skills to enable planning, prioritization, and achievement of goals, especially for the successful execution of related activities.
• Ability to read and interpret data, information, and documents.
• Ability to work well with others in a variety of situations.
• Able to multi-task, work under time constraints, problem-solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems.