Senior Quality Systems Specialist, QMS & Compliance

West Pharmaceutical Services, Inc; Exton (PA); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

PTO

Tuition assistance

Global career opportunities

Hybrid work environment

Job summary

West Pharmaceutical Services, Inc. in Exton, PA is seeking a Senior Associate, Quality Systems for a hybrid role requiring onsite presence at least 3 days per week. The role focuses on governance, harmonization, and continuous improvement of QMS across the Vantage manufacturing network.

You will lead Change Management, CAPA, Global Alerts, Management Review, Quality Metrics, and Document Control, partnering with site QA teams to ensure regulatory compliance and risk-based decision-making.

Qualifications

• Bachelor qualification in Engineering/Quality or Science.
• 5+ years’ experience in a high-volume manufacturing environment, ideally in the medical device / pharmaceutical sector.
• Thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 QMSR.

Responsibilities

• Manage and coordinate designated Vantage OU QMS processes, including Change Management, CAPA, Global Alerts, Management Review, Quality Metrics, Tier 4 Reporting, and OU-level Document Control.
• Ensure Vantage OU quality processes are standardized, harmonized, effectively deployed, and consistently applied across all Vantage sites.
• Support governance of the Vantage CAPA process, including CAPA Review Board coordination, escalation, prioritization, timeliness, quality, and effectiveness monitoring.
• Drive systemic root cause analysis, cross-site learning, and risk-based corrective and preventive actions across the Vantage network.
• Provide OU-level Change Control oversight to ensure appropriate impact assessment, cross-site alignment, regulatory/customer considerations, and customer notification where required.

Education

Bachelor qualification in Engineering/Quality or Science

Job description

West Pharmaceutical Services, Inc. in Exton, PA is seeking a Senior Associate, Quality Systems for a hybrid role requiring onsite presence at least 3 days per week. The role focuses on governance, harmonization, and continuous improvement of QMS across the Vantage manufacturing network.

You will lead Change Management, CAPA, Global Alerts, Management Review, Quality Metrics, and Document Control, partnering with site QA teams to ensure regulatory compliance and risk-based decision-making.