Senior Specialist - IT Quality and Computerized Systems Validation

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

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.

Position Summary

Reporting into the Senior Manager, BI&T Quality and Compliance for the Leiden Cell Therapy Facility (CTF), the Senior Specialist, IT Quality and Computerized Systems Validation will provide subject matter expertise and hands-on support for Computer System Validation (CSV) and IT Compliance activities for the Leiden Cell Therapy Facility on an ongoing basis.

Key Responsibilities

• The Senior Specialist, IT Quality and Computerized Systems Validation, role will provide hands-on support for computerized system validation (CSV) activities, projects, deviations, and change controls related to computerized systems.


• Demonstrated working knowledge of the principles theories and concepts of computerized systems validation/compliance (GAMP5)


• Act as CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects, providing technical input to operations on CSV matters and supporting inspection or audit readiness activities as needed.


• Support the CSV program by contributing to standardized and consistent qualification testing documents and associated testing deviation documentation.


• Review and approve qualification documents as part of CSV activities, supporting the pre- and post-approval of qualification testing.


• Support regulatory audits as a Digital Plant representative by providing CSV and IT compliance input and assisting with responses to audit observations.


• Provide IT quality support to the Leiden CTF Digital Plant team through quality review of investigations or change controls, support for computerized system deviations, and execution of CSV activities.


• Interact with Infinity (Change Management system) to enter deviations and associated actions, investigations, and associated root cause analyses, supporting data, corrective action/preventative action (CAPA), and effectiveness reviews as needed.


• Support project and audits as assigned.


• Support the periodic review and update of Digital Plant standard operating procedures (SOPs) and procedural methodologies used to maintain the validated state.


• Assist in development of appropriate validation methodologies in collaboration with Operations


• Provide CSV input to multi-function teams, advise operations on CSV matters within area of expertise, and support inspection or audit readiness activities.


• Duties may include supporting internal compliance or efficiency improvement efforts within the department.

Qualifications & Experience

• Bachelor's in engineering, IT, Science field or equivalent.


• Minimum 3+ years of 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.


• Demonstrated ability to work effectively in a high-performing, business results-driven environment.

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 workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonab