IT Quality & CSV Lead: Cell Therapy Compliance

Bristol Myers Squibb; Leiden; On-site; EUR 90,000 - 140,000; Full time

Job summary

Bristol Myers Squibb is seeking a Manager - IT Quality and Computerized Systems Validation to lead CSV and IT compliance for the Leiden Cell Therapy Facility. The role provides SME guidance on CSV and regulatory matters, manages testing documentation, and supports audits across the Digital Plant landscape.

You will work with cross-functional teams, ensure validated state of systems, and align IT quality with cGMP and GxP requirements in a bio-tech manufacturing setting at Leiden.

Qualifications

• Bachelor’s in engineering, IT, Science field or equivalent.
• Minimum 5+ years’ relevant industry experience. Prior Cell Therapy experience is highly valued but not required.
• Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
• Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation, Historians and Benchtop systems in QC and MFG.
• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
• Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 and good documentation practices.

Responsibilities

• Provide subject matter expertise and lead the Computer System Validation (CSV) and IT Compliance function for the Leiden Cell Therapy Facility on an ongoing basis.
• Serve as CSV SME for changes and advise operations on CSV matters and defend their work before regulatory agencies.
• Manage CSV program, standardize qualification testing documents and testing deviations.
• Review and approve qualification documents as part of CSV activities, supporting pre- and post-approval of testing.
• Participate in regulatory audits as Digital Plant representative and assist in audit responses.
• Provide IT quality support to Leiden CTF Digital Plant team through quality review and approval of investigations or change controls.
• Interact with Infinity to enter deviations and actions, investigations and CAPA, and conduct root cause analyses.
• Perform project audits as needed and ensure SOPs and methodologies stay updated.
• Assist in developing validation methodologies with Operations and provide CSV input to multi-function teams.

Skills

CSV

GAMP5

IT Quality

Regulatory audits

SDLC

GxP

Regulatory compliance

Education

Bachelor’s in engineering/IT/science

Tools

MES

LIMS

QMS

ERP

Historians

Benchtop systems

Job description

Bristol Myers Squibb is seeking a Manager - IT Quality and Computerized Systems Validation to lead CSV and IT compliance for the Leiden Cell Therapy Facility. The role provides SME guidance on CSV and regulatory matters, manages testing documentation, and supports audits across the Digital Plant landscape.

You will work with cross-functional teams, ensure validated state of systems, and align IT quality with cGMP and GxP requirements in a bio-tech manufacturing setting at Leiden.