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?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
In this role, you will be responsible for leading and maintaining 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 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 customer complaint trends.
- Drive continuous improvement initiatives to improve 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.
- Other duties as assigned
Additional Responsibilities
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
Education
- Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, Quality, or a related scientific discipline. or equivalent experience
Work Experience
- 10+ years 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, and 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 Knowledge, Skills And Abilities
- 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.
License and Certifications
Travel Requirements
10%: Up to 26 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or 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.
Additional Requirements
- Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
- Able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
- Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
- Read and interpret data, information and documents
- Maintain the 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
What We Offer
Shift
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.
