Senior Manager Compliance Manufacturing Compliance

17 uur geleden

Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd

Transforming Lives through Compliance

Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. We are seeking a highly skilled Senior Manager Compliance, Manufacturing Compliance & Support to join our team in the Netherlands.

About the Role

The Senior Manager Compliance, Manufacturing Compliance & Support will be responsible for managing the Manufacturing Compliance & Support operations activities, ensuring quality compliance, and representing the company in review boards. This role will also lead a team of specialists in a matrix organization to deliver on full C&S scope.

Key Responsibilities

  • Identify, assess, and prioritize potential risks and implement strategies to mitigate their impact.
  • Drive quality record turnaround time (TAT) improvements.
  • Accountable for on-time completion of MFG deviations, CAPAs, and CCs.
  • Represent the company in all applicable cross-functional local and global review boards.
  • Develop, manage, and report on manufacturing compliance KPIs.
  • Coordinate corrective actions with MFG operations and C&S technical training.
  • Responsible for level loading deviations throughout all C&S specialists.
  • Accountable for manufacturing business continuity planning.
  • Lead and/or represent manufacturing for internal/external inspections.
  • Responsible for driving manufacturing inspection readiness.
  • Accountable for Aseptic Process Simulation life cycle management, execution, and reporting.

Requirements

  • Minimum of 7 years of relevant manufacturing experience.
  • Minimum of 5 years leadership experience, including the management of direct reports.
  • Minimum of 3 years in a Quality Assurance role managing deviations and CAPAs.
  • 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.
  • Excellent communication skills.

About Bristol Myers Squibb

Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, the Netherlands. We are committed to making a positive impact on the lives of patients and communities around the world.

Why Join Us?

At Bristol Myers Squibb, we offer a dynamic and inclusive work environment that fosters collaboration, innovation, and growth. We are committed to developing our employees' skills and careers, and we offer a range of benefits and programs to support their well-being.

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