Senior IT Quality & CSV Specialist

Bristol Myers Squibb; Leiden; On-site; EUR 70,000 - 100,000; Full time

Job summary

Bristol Myers Squibb in Leiden seeks a Senior Specialist, IT Quality and Computerized Systems Validation to lead CSV and IT compliance activities at the Leiden Cell Therapy Facility. You will provide SME guidance, ensure validated systems, and support audits.

You will collaborate with operations, apply GAMP5, 21 CFR Part 11 and EudraLex Annex 11, and contribute to QA reviews, change controls, deviations, and CAPA to maintain regulatory readiness and product quality.

Qualifications

• Bachelor's in engineering, IT, science or equivalent.
• Minimum 3+ years of relevant industry experience in bio-tech/pharma.
• Demonstrated experience with IT Quality & Compliance applications and systems.
• Understanding of supply chain, manufacturing and quality domains with MES, LIMS, QMS, ERP.
• Knowledge of regulatory requirements (GxP) and SDLC, 21 CFR Part 11, EudraLex Annex 11.

Responsibilities

• Provide hands-on CSV activities, projects, deviations, and change controls for computerized systems.
• Act as CSV SME for changes and IT/Automation projects; support inspections/audits.
• Support CSV program with standardized qualification testing documents and deviation documentation.
• Review and approve qualification documents for CSV activities; assist pre/post-approval of testing.
• Support regulatory audits as Digital Plant representative; provide CSV input and respond to observations.
• Provide IT quality support to the Leiden CTF Digital Plant team; review investigations and CAPA.
• Interact with Infinity Change Management to enter deviations and actions; support root cause analyses.

Skills

IT Quality & Compliance experience

Regulatory knowledge (GxP)

GAMP5 / CSV best practices

Change control & CAPA handling

Education

Bachelor's in engineering/IT/science

Tools

MES

LIMS

QMS

ERP

Job description

Bristol Myers Squibb in Leiden seeks a Senior Specialist, IT Quality and Computerized Systems Validation to lead CSV and IT compliance activities at the Leiden Cell Therapy Facility. You will provide SME guidance, ensure validated systems, and support audits.

You will collaborate with operations, apply GAMP5, 21 CFR Part 11 and EudraLex Annex 11, and contribute to QA reviews, change controls, deviations, and CAPA to maintain regulatory readiness and product quality.