IT Compliance Lead — GMP & CSV Assurance

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

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.