Quality Systems Manager - Regulatory & Audit Readiness

RXinsider LTD.

Greenfield (IN)

On-site

USD 120,000 - 150,000

Full time

6 days ago

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Job summary

West Pharmaceutical Services, Indiana site, seeks a Quality Systems Manager to lead governance, regulatory readiness, supplier quality governance, and continuous improvement of the QMS. You will ensure inspection readiness and lead the Quality Systems team under the Site Quality Director.

Ideal candidates have 8+ years of quality/regulatory management in process manufacturing for medical devices or pharmaceuticals, with strong leadership and audit experience, and proficiency with MS Office and

Qualifications

8+ years of Quality/Regulatory management in process-based manufacturing
Experience with EU GMP, 21 CFR Part 210/211 and Part 4, ISO13485
Experience hosting customer, corporate and regulatory audits/inspections
Proven leadership in Quality Systems and compliance programs

Responsibilities

Lead and coach the Quality Systems team with performance management
Own the site QMS governance, compliance, and continual improvement
Oversee deviations, CAPA, change control, document control, training and Management Review
Lead audit readiness and act as primary Quality Systems representative during audits
Provide regulatory compliance leadership and monitor evolving requirements