Quality Systems Leader - Onsite & Regulatory Readiness

West Pharmaceutical Services

Greenfield (IA)

On-site

USD 110,000 - 140,000

Full time

5 days ago

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Job summary

West Pharmaceutical Services in Greenfield, IA, is seeking a Quality Systems Manager to drive governance, compliance, and continual improvement of the Quality Management System (QMS) across the site. You will lead the Quality Systems team, ensure regulatory readiness, and oversee supplier quality governance, risk management and continuous improvement initiatives.

Reporting to the Site Quality Director, you will manage audits, CAPA, change control, and validation programs while aligning with

Qualifications

Minimum 8 years of Quality/Regulatory management in process-based manufacturing for medical devices/pharmaceuticals.
Experience with EU GMP, 21 CFR 210/211/Part 4, ISO13485, 21 CFR Part 820 QMSR.
Proven experience hosting audits/inspections and maintaining a QMS for US and EU markets.

Responsibilities

Lead the Quality Systems team through performance management and capability development.
Own the site QMS governance, compliance, ownership of processes, and continual improvement.
Oversee deviations, CAPA, change control, complaints, document control, training, Management Review, and supplier quality governance.
Develop and implement the site Quality Systems strategy aligned with regulatory and customer requirements.
Lead audit readiness and act as primary Quality Systems representative during customer, regulatory and Notified Body audits.