Manager - IT Quality and Computerized Systems Validation

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.

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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 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 Operations

• Provide CSV input to multi-function teams, advises operations on CSV matters, and defend their work before regulatory agencies.

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

Qualifications & Experience

• 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.

• Demonstrated success working in a high-performing, business results-driven environment.

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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R1603397 : Manager - IT Quality and Computerized Systems Validation