Senior Manager Compliance Manufacturing Compliance

4 weken geleden


Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

Transforming Lives Through Compliance

Bristol Myers Squibb is a leader in the pharmaceutical industry, and we're looking for a Senior Manager Compliance Manufacturing Compliance to join our team. As a key member of our manufacturing organization, you will be responsible for managing compliance and quality assurance operations, ensuring that our products meet the highest standards of quality and safety.

Key Responsibilities

  • Identify and assess potential risks, implementing strategies to mitigate their impact on compliance and safety.
  • Drive quality record turnaround time improvements, ensuring timely completion of manufacturing deviations, CAPAs, and CCs.
  • Represent manufacturing in cross-functional review boards, developing and managing manufacturing compliance KPIs.
  • Coordinate corrective actions with manufacturing operations and C&S technical training, embedding changes into routing operations training.
  • Lead and/or represent manufacturing for internal/external inspections, driving manufacturing inspection readiness.
  • Accountable for Aseptic Process Simulation life cycle management, execution, and reporting.

Requirements

  • Minimum 7 years of relevant manufacturing experience, including 5 years of leadership experience and 3 years in a Quality Assurance role.
  • Extensive knowledge of EOHSS, cGMPs, and ATMPs regulations and principles.
  • Demonstrated proficiency in departmental organizational development, adaptable to a fast-paced, complex, and dynamic business environment.
  • Knowledge of lean manufacturing principles and excellent communication skills.


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