Senior Manager, IT Compliance Lead
vor 3 Wochen
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 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. 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.
- 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.
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.
- Widespread IT technical knowledge such as Operating Systems, 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 skills.
- Analytical and structured working style; strong attention to detail.
- Ability to effectively work as part of a multidisciplinary, international team.
- Hands-on personality.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through scienceTM,” 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.
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