IT Quality and Compliance Manager

1 maand geleden

Leiden, Zuid-Holland, Nederland Bristol-Myers Squibb Voltijd
Transforming Patients' Lives through Science

Bristol-Myers Squibb is a company that is pushing the boundaries of what is possible in the field of biotechnology. We are seeking a highly skilled and experienced IT Quality and Compliance Manager to join our team.

Key Responsibilities
  • Develop and implement Computer System Validation Protocols, including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, protocols.
  • Develop a complete understanding of BMS policies and procedures related to all aspects of computer system validation.
  • Liaise with cross-functional SMEs in developing and promulgating the computer system validation methodology for the Cell Therapy function.
  • Participate actively with other groups to analyze and address process deficiencies, working collaboratively with peers within various departments and Quality groups.
  • Provide validation subject matter expertise (SME) in the Digital Plant environment and contribute to multi-function teams, advising personnel on validation matters and defending their work before regulatory agencies and auditors.
  • Provide CSV expertise and guidance related to management, peers, and lower-level professionals.
Qualifications and Experience
  • Bachelor's degree in Engineering, IT, Science field or equivalent.
  • Minimum 10+ years of relevant industry experience, with prior Cell Therapy experience highly valued but not required.
  • Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
  • Understanding of, and experience with, supply chain, manufacturing, and quality domains and supporting technology, including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation, and Historians.
  • Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
  • Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and meet regulatory requirements.
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11, and good documentation practices.
  • Demonstrated success working in a high-performing, business results-driven environment.

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