Transforming Patients' Lives Through Science
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
About This Role
The IT Compliance Lead will oversee and enhance the organization's IT compliance and risk management. This leadership role leverages 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.
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.
* Fosters a quality culture throughout all internal initiatives.
* Foster streamlining and process simplification.
* Coordinates the qualification of the site IT infrastructure with global/corporate teams.
* Oversees and defines quality expectations and provides support to the IT department and 3rd parties to ensure effective implementation of systems that meet GMP requirements.
* Manages and prioritizes IT activities supporting Quality Assurance using a risk-based approach.
* Acts as a Quality Ambassador towards other functions and third parties to comply with BMS quality standards.
* Supports Data Integrity program and remediation activities.
* Supports the conversion of IT compliance requirements into test conditions (FAT, SAT, IQ, OQ, PQ).
* Understands business objectives, processes, and strategies.
* Able to work strategically and independently with internal and external groups on multiple simultaneous projects.
* Understands and ensures the use of existing standards for design and governance.
What You Will Need
To be successful in this role you will need:
* 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, 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.
Join Our Team
We are an inclusive culture promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.