Manager - IT Quality and Computerized Systems Validation
Leiden, NetherlandsPosted Jun 10, 2026
Career Areas Career Stories Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Careers Home Life at BMS Career Areas Student Opportunities Events How We Recruit Career Stories Search this site Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Single PositionView All JobsManager - IT Quality and Computerized Systems ValidationLeiden – NLApply NowFind out how well you match with this jobUpload your resumeJob descriptionLife at BMSWorking with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Position SummaryReporting into the Senior Manager, BI&T Quality and Compliance for the Leiden Cell Therapy Facility (CTF), the Manager, IT Quality and Computerized Systems Validation will 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.Key ResponsibilitiesThe Manager, IT Quality and Compliance, role will provide support through managing the computerized system validation (CSV) activities / major projects and supporting deviations and changing 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 – advising operations on CSV matters and defending their work before regulatory agencies.Manages CSV program, ensuring standardization and consistency of qualification testing documents and associated testing deviations.Review and approve qualification documents as part of CSV activities, supporting the pre- and post-approval of qualification testing.Participates in regulatory audits as Digital Plant representative and assists in generating responses to audit observations.Provides IT quality support to Leiden CTF Digital Plant team through quality review and approval of investigations or change controls, deviation ownership of computerized system events, and 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.Perform project audits as the needs arise.Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated, as needed.Assist in development of appropriate validation methodologies in collaboration with OperationsProvide CSV input to...