IT Compliance Lead

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Position Summary

The IT Compliance Lead will oversee and enhance the organization’s IT compliance, 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. The IT Compliance Lead 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.
• 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 ensure the use of existing standards for design and governance.

Location

Boudry, Switzerland

Reporting Relationship

This position reports to the Director of Digital Plant and Site IT Lead

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 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.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in 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.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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