Bristol Myers Squibb
bio-tech
Manager-ITQualityandComputerizedSystemsValidation
Neural analysis suggests this role is
optimal for Manager candidates.
“Manager - IT Quality and Computerized Systems Validation at Bristol Myers Squibb. Skills: Computerized Systems Validation, IT Compliance, GxP. Provide subject matter expertise. Lead Computer System Validation”
Industry & Context.
Root cause analyses
What They're Looking For.
Must Have
Bachelor's in engineering, IT, Science, Minimum 5+ years relevant industry experience, Demonstrated experience with IT Quality & Compliance applications, Experience with supply chain, manufacturing and quality domains, Working knowledge of regulatory requirements, Knowledge of industry standard Quality and Compliance methodology, Knowledge of cGMP, GXP, GAMP, SDLC regulations, Knowledge of 21CFR part 11, Knowledge of EudraLex Annex 11, Knowledge of good documentation practices
Nice to Have
Prior Cell Therapy experience
What You'll Do.
Provide subject matter expertise
Lead Computer System Validation
Lead IT Compliance function
Manage computerized system validation activities
Support change controls
Act as CSV Subject Matter Expert
Advise operations on CSV matters
Defend work before regulatory agencies
Ensure standardization of qualification testing documents
Ensure consistency of qualification testing documents
Review qualification documents
Approve qualification documents
Support pre-approval of qualification testing
Support post-approval of qualification testing
Participate in regulatory audits
Assist in generating responses to audit observations
Provide IT quality support
Quality review investigations
Approve investigations
Quality review change controls
Approve change controls
Deviation ownership of computerized system events
Perform project audits
Ensure Digital Plant SOPs are updated
Update procedural methodologies
Assist in development of validation methodologies
Provide CSV input to teams
Perform internal compliance efforts
Perform efficiency improvement efforts
How You'll Work.
Team & Collaboration
Digital Plant representative; Multi-function teams
Communication Scope
Defend work before regulatory agencies
Process & Methodology
Change Management
Full Job Description
**Working with Us** Challenging. 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](https://careers.bms.com/working-with-us). **Position Summary** Reporting 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 Responsibilities** * The 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 testi
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