QA Compliance & QMS Lead - GMP & Audits

WuXi Biologics; Cranbury Township (NJ); Vor Ort; USD 90.000 - 150.000; Vollzeit

Zusammenfassung

WuXi Biologics in Cranbury, NJ, United States is seeking a QA Compliance / QMS Manager to oversee the site Quality Management System, ensuring GMP compliance, client expectations, and regulatory standards. The role emphasizes coordination of quality events, audits, inspection readiness, and continuous improvement within a dynamic GMP environment.

You will lead cross-functional teams across QA, Manufacturing, QC, Engineering, and Validation; manage deviations, CAPAs, change controls, and

Qualifikationen

• Bachelor's degree or higher in Life Sciences, Engineering, Pharmacy, Chemistry, Biotechnology, or related discipline; advanced degree preferred.
• Experience in Quality Assurance, Quality Systems, Compliance, Manufacturing, QC, or GMP-regulated environment preferred.
• Working knowledge of GMP regulations and Quality Management Systems.

Aufgaben

• Coordinate and support site Quality Event activities (deviations, CAPAs, change controls, quality records).
• Monitor open Quality Events, due dates, aging, risks, and closure status with proactive follow-up.
• Identify bottlenecks or compliance risks and work with cross-functional teams to implement action plans.

Kenntnisse

GMP knowledge

Quality systems

Cross-functional collaboration

Project coordination

Communication skills

Problem-solving

Adaptability

Ausbildung

Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry, Biotechnology, or related field

Tools

TrackWise

MasterControl

Veeva

Jobbeschreibung

WuXi Biologics in Cranbury, NJ, United States is seeking a QA Compliance / QMS Manager to oversee the site Quality Management System, ensuring GMP compliance, client expectations, and regulatory standards. The role emphasizes coordination of quality events, audits, inspection readiness, and continuous improvement within a dynamic GMP environment.

You will lead cross-functional teams across QA, Manufacturing, QC, Engineering, and Validation; manage deviations, CAPAs, change controls, and