Quality Assurance Manager

2 weken geleden

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

Bristol-Myers Squibb is a company that pushes the boundaries of what's possible in the field of biotechnology. We're not just looking for talented individuals to join our team; we're seeking passionate professionals who share our vision of transforming patients' lives through science.

About the Role

We're seeking a highly skilled Quality Assurance Manager to join our team in Leiden. As a key member of our IT Quality and Compliance department, you will be responsible for ensuring that our computer systems meet the highest standards of quality and regulatory compliance.

Your primary focus will be on developing and implementing computer system validation protocols, including validation master plans, design documents, process and instrumentation drawings, IQ, OQ, and protocols. You will also be responsible for developing a complete understanding of BMS policies and procedures related to computer system validation and liaising with cross-functional SMEs to develop and promulgate the computer system validation methodology for the Cell Therapy function.

As a Quality Assurance Manager, you will work collaboratively with peers within various departments and Quality groups to analyze and address process deficiencies. You will also 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.

Key Responsibilities
  • Develop and implement computer system validation protocols
  • Develop a complete understanding of BMS policies and procedures related to computer system validation
  • Liaise with cross-functional SMEs to develop and promulgate the computer system validation methodology for the Cell Therapy function
  • Work collaboratively with peers within various departments and Quality groups to analyze and address process deficiencies
  • Provide validation subject matter expertise (SME) in the Digital Plant environment
  • Contribute to multi-function teams, advising personnel on validation matters and defending their work before regulatory agencies and auditors
Qualifications and Experience

We're looking for a highly skilled professional with a Bachelor's degree in Engineering, IT, or a related field and a minimum of 10+ years of relevant industry experience. Prior Cell Therapy experience is highly valued, but not required. You should have demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment and a working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.

You should also have knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and meet regulatory requirements. Additionally, you should have knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11, and good documentation practices.

We're looking for a team player who can work in a high-performing, business results-driven environment and has demonstrated success in a similar role. If you're passionate about transforming patients' lives through science and have the skills and experience we're looking for, we encourage you to apply for this exciting opportunity.

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