Manager II - IT Compliance Lead
Bristol Myers Squibb · Boudry, Switzerland
IT & SoftwareFull-timeCompany career page
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Role summary
Bristol Myers Squibb seeks a Manager II - IT Compliance Lead for its Boudry, Switzerland manufacturing site. The role oversees IT systems compliance, quality assurance, and regulatory adherence while leading cross-functional teams and managing computer system validation activities.
What they're looking for
- Bachelor of Science degree required
- 5-7 years pharmaceutical or related industry experience
- Expert knowledge of Computer System Validation (CSV)
- Deep understanding of 21-CFR Part 11, EudraLex, and MHRA regulations
- IT technical knowledge: operating systems, infrastructure, networking, systems
- Fluent English; French language strongly preferred
- Data Integrity and Quality Management Systems experience
What you'll be doing
- Oversee IT systems compliance with EU-GMP Annex 11 and 21-CFR Part 11 regulatory requirements
- Lead infrastructure qualification and GxP computerized systems lifecycle management
- Serve as primary liaison between GPS IT Boudry team and QA Compliance team
- Support deviation assessments, investigations, and remediation activities for IT systems
- Facilitate cross-functional meetings, mentor staff, and drive process improvement initiatives
Privacy & handoff
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