About Bristol Myers Squibb
At Bristol Myers Squibb, we offer a unique and challenging work environment that allows you to grow and thrive. Our company is committed to transforming the lives of patients and the careers of our employees.
Senior Manager, IT Compliance Lead Job Summary
This leadership role oversees and enhances the organization's IT compliance and risk management. The successful candidate will leverage 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.
Main Responsibilities:
* Lead and support a team of IT compliance experts.
* Ensure site IT systems compliance with regulatory requirements and CSV procedures.
* Establish a cross-functional network with the business to support manufacturing operations.
* Supervise internal and external audits.
* Monitor and coordinate quality activities for the IT GPS department at Boudry.
* Serve as the CMDB owner to ensure alignment with global and Boudry standards.
* Foster a quality culture throughout internal initiatives.
* Streamline and simplify processes.
* Coordinate the qualification of the site IT infrastructure with global/corporate teams.
* 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.
Qualifications
* Bachelor of Science degree 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.
* 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.