Quality Systems Lead: Compliance & CAPA Expert

West Pharmaceutical Services, Inc; Greenfield (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

West Pharmaceutical Services, Inc. is seeking a Senior Quality Systems Specialist in Greenfield, Indiana to oversee quality management systems and drive continuous improvement.

The role requires coordinating activities for timely closure of quality issues and ensuring compliance with regulatory and customer standards. The candidate should have a minimum of 5 years in a high‑volume manufacturing environment (pharma preferred), with knowledge of ISO 13485 and 21 CFR Part 820 QMSR.

Qualifications

• Minimum 5 years’ experience in a high‑volume manufacturing environment (pharma preferred).
• Working knowledge of ISO 13485 / 21 CFR Part 820 QMSR/21 CFR Part 210/211 is essential.

Responsibilities

• Harmonize and deploy site quality systems into standardized processes across the network.
• Provide training on QMS processes including CAPA, Deviation Management, Document Control, and Change Management.
• Manage key quality system processes at site level (Global Alerts, CAPA governance, Change Management oversight).
• Lead investigations with robust root cause analysis and corrective/preventive actions.
• Monitor quality system performance via metrics and trend analysis; report to senior leadership.

Skills

Quality systems knowledge

Regulatory compliance

Auditing experience

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering, Quality, Science or equivalent experience

Job description

West Pharmaceutical Services, Inc. is seeking a Senior Quality Systems Specialist in Greenfield, Indiana to oversee quality management systems and drive continuous improvement.

The role requires coordinating activities for timely closure of quality issues and ensuring compliance with regulatory and customer standards. The candidate should have a minimum of 5 years in a high‑volume manufacturing environment (pharma preferred), with knowledge of ISO 13485 and 21 CFR Part 820 QMSR.