Manager II - IT Compliance Lead

Bristol Myers Squibb; Boudry; Vor Ort; CHF 140.000 - 210.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb, based in Boudry, Switzerland, seeks a Manager II - IT Compliance to oversee GMP-aligned IT systems, drive risk-based activities, and lead cross-functional IT compliance projects at the Boudry site.

With 5–7 years pharma experience and expertise in CSV, 21-CFR Part 11, and Data Integrity, you will translate compliance requirements into testing, validation, and continuous improvement, working in English with French as a strong plus. On-site role at Boudry site.

Qualifikationen

• Bachelor of Science degree required, minimum of 5-7 years of experience in the pharmaceutical or related industry.
• Pharmaceutical, Biotechnology, and Life Science industry experience is a must.
• 5 years’ experience in a similar role within pharmaceutical industry.
• IT technical knowledge such as Operating System, Infrastructure and Networking and Systems.
• Broad working knowledge of Quality Management Systems.
• Knowledge of GxP systems (MES, LIMS…)
• University degree in Quality, Engineering, Sciences or another relevant discipline.
• Expert in Computer System Validation (CSV).
• Deep knowledge of 21-CFR Part 11, EudraLex, MHRA.
• Experience in Data Integrity requirements
• Fully operational in English, French language a strong plus
• Works independently or with minimal supervision.
• Autonomous in analysis, problem solving and delivering.

Aufgaben

• Interpret, implement, and monitor Quality systems and GMP compliance.
• Main point of contact between GPS IT Boudry team and QA Compliance team.
• Communicate effectively on cross-departmental teams.
• Promote Quality Culture across internal initiatives; act as a Quality Ambassador.
• Analyze data, identify gaps, and recommend compliance solutions.
• Oversee IT infrastructure qualification and GxP system lifecycle for compliance.
• Support infrastructure integration on the Boudry site and ensure compliance.
• Translate compliance requirements into test conditions and validation activities.
• Support deviation assessments and investigations pertaining to IT.
• Write reports and presentations related to IT Compliance.
• Maintain local IT documentation aligned with global and local requirements.
• Provide training and mentorship to staff.
• Identify and lead process or system improvement projects.

Kenntnisse

Pharma industry experience

GxP systems knowledge

CSV expertise

IT infrastructure know-how

Data integrity

English fluency

French preferable

Ausbildung

Bachelor of Science degree

University degree in Quality, Engineering, Sciences

Expert in Computer System Validation (CSV)

Tools

NA

Jobbeschreibung

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Integrated into the GPS IT Boudry department, Manager II - IT Compliance provides quality oversight on Boudry site IT systems and solutions through effective internal and cross-functional collaboration.

Working location is Boudry, Switzerland. All activities will focus on the Boudry Manufacturing site facilities with potential cross-functional links with other Bristol-Myers Squibb sites.

Drives risk-based activities, process improvements, and supports audits and remediation.

Facilitates cross-functional collaboration, leads meetings on IT topics, and works independently across multidisciplinary teams to maintain continuous compliance and operational excellence.

Duties/Responsibilities

• The accountability of the worker is the interpretation, implementation, and continuous monitoring of Company expectations to ensure robust quality systems and GMP compliance.
• Serves as the main point of contact between GPS IT Boudry team and QA Compliance team
• Communicate effectively on cross-departmental teams
• Promotes Quality Culture across all internal initiatives. Acts as a Quality Ambassador towards other functions and third parties to comply with BMS quality standards
• Has a comprehensive understanding of departmental goals, processes, and the ability to collaborate across functions.
• Ability to analyze and interpret data, identify gaps, and recommend solutions to support compliance, and regulatory objectives
• Oversee the strategy for Infrastructure qualification and GxP computerized systems, managing their lifecycle to ensure continuous compliance with regulatory and internal requirements.
• Supports Infrastructure integration on the Boudry site and ensure that the installation is compliant according to internal process.
• Assists the translation of compliance requirements into test conditions and expected results for application functionality, and acceptance testing (FAT, SAT, IQ, OQ, PQ)
• Supports or conducts deviation assessments and investigations pertaining to Information Technology.
• Proficient in writing reports/documents and presentations related to IT Compliance activities
• Manage local IT documentation, ensuring it stays aligned with the current state of IT systems and complies with both global and local requirements and quality standards.
• Provide training and serve as a mentor.
• Identifies, executes and leads process or system improvement projects
• Adopts a culture of ethics, leads by example and challenges non-compliance.
• 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 Computer System Validation (CSV) procedures.
• Oversees and defines quality expectations and provides support to the GPS IT department and 3rd parties to ensure effective implementation of systems that meet GMP requirements
• Anticipates and prioritize IT activities that support Quality Assurance based on risk-based approach
• Integrates risk management into the decision-making process for IT compliance activities.
• Supports Data Integrity program and remediation activities
• Facilitate meetings with business colleagues on IT topics
• Understands business objectives, processes, and strategies
• Able to work strategically and independently with internal and external groups on multiple simultaneous projects

Qualifications

Bachelor of Science degree required, minimum of 5-7 years of experience in the pharmaceutical or related industry

Specific Knowledge, Skills, Abilities

• Pharmaceutical, Biotechnology, and Life Science industry experience is a must.
• 5 years’ experience in a similar role within pharmaceutical industry
• IT technical knowledge such as Operating System, Infrastructure and Networking and Systems.
• Broad working knowledge of Quality Management Systems
• Knowledge of GxP systems (MES, LIMS…)

Education/Experience/ Licenses/Certifications

• University degree in Quality, Engineering, Sciences or another relevant discipline
• Expert in Computer System Validation (CSV)
• Deep knowledge of 21-CFR Part 11, EudraLex, MHRA
• Experience in Data Integrity requirements
• Fully operational in English, French language a strong plus
• Works independently or with minimal supervision.
• Autonomous in analysis, problem solving and achieving deliverables
• Exceptional Oral and Written communication
• Analytical and structured working style; strong attention to detail
• Ability to effectively work as part of a multidisciplinary, international team
• Hands-on personality

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request reasonable workplaceaccommodations/adjustmentsprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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For roles based in Los Angeles County only: 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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If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605686 : Manager II - IT Compliance Lead