Compliance Risk Management Lead

Vor 4 Tagen

Boudry District, Schweiz Bristol-Myers Squibb Vollzeit

About the Role

The IT Compliance Lead will be responsible for overseeing and enhancing the organization's IT compliance and risk management. This leadership role requires expertise in all aspects of IT compliance, including Computerized System Validation (CSV), to guide strategic decision-making, ensure regulatory adherence, and address emerging cybersecurity and compliance challenges.

This role will collaborate with cross-functional teams, oversee internal and external audits, and serve as a trusted advisor to senior leadership. A key part of the role involves fostering a compliance-driven culture and driving continuous improvement in governance and risk management practices.

Key Responsibilities:

  • Lead and support a team of IT compliance experts.
  • Responsible for supporting site IT systems compliance, ensuring these are maintained in accordance with regulatory requirements (EU-GMP Annex 11 & 21-CFR part 11) and Computerized System Validation (CSV) procedures.
  • Establish a cross-functional network with the business to support manufacturing operations.
  • Supervise internal and external audits.
  • Responsible for the ongoing monitoring of company expectations to ensure strong quality systems and GMP compliance.
  • Oversee, monitor, and coordinate the activities that support the quality for IT GPS (Global Product Development & Supply) department at Boudry.
  • Serve as the CMDB (Configuration management database) owner to ensure it is managed in alignment with both global and Boudry standards.
  • Foster a quality culture throughout all internal initiatives.
  • Foster streamlining and process simplification.
  • Coordinate the qualification of the site IT infrastructure with global/corporate teams.
  • Oversee and define quality expectations and provide support to the IT department and 3rd parties to ensure effective implementation of systems that meet GMP requirements.
  • Manage and prioritize IT activities supporting Quality Assurance using a risk-based approach.
  • Act as a Quality Ambassador towards other functions and third parties to comply with BMS quality standards.
  • Support Data Integrity program and remediation activities.
  • Support the conversion of IT compliance requirements into test conditions (FAT, SAT, IQ, OQ, PQ).
  • Understand business objectives, processes, and strategies.
  • Able to work strategically and independently with internal and external groups on multiple simultaneous projects.
  • Understand and ensure the use of existing standards for design and governance.

Qualifications:

  • A Bachelor of Science degree is required, along with a minimum of ten years of experience in the pharmaceutical or biotechnology industry.
  • Demonstrated experience in managing teams.
  • 10 years' experience in a similar role within the pharmaceutical industry.
  • Proficiency in general IT Compliance activities including Computerized System Validation (CSV) in the pharmaceutical environment and relevant regulations is required.
  • Widespread IT technical knowledge such as Operating System, Infrastructure, and Networking and Systems.
  • Advanced knowledge of Change Control Management (ITIL).
  • Broad working knowledge of Quality Management Systems.
  • Extensive experience in supporting the quality aspects of GXP systems (ERP, MES, LIMS, etc.).
  • Green Belt or Black Belt Lean Six Sigma certification is a plus.
  • University degree in Quality, Engineering, Sciences, or another relevant discipline.
  • Expert in Computerized System Validation (CSV).
  • Deep knowledge of 21-CFR Part 11, EudraLex, MHRA.
  • Experience in Data Integrity requirements.
  • Fully operational in French and English.
  • Autonomous in analysis, problem solving, and achieving deliverables.
  • Exceptional Oral and Written communication.
  • Analytical and structured working style; strong attention to details.
  • Ability to effectively work as part of a multidisciplinary, international team.
  • Hands-on personality.

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