Manager, BI&T Computer Software Validation (CSV)

The Manager BI&T Computer Software Validation (CSV) at Bristol Myers Squibb is responsible for developing and implementing validation methodologies for IT systems at the Leiden site. This involves drafting and reviewing validation protocols, including masterplans, design documents, IQ, and OQ. The role requires a deep understanding of BMS policies and regulatory requirements like GxP, GAMP, and 21CFR part 11. The manager collaborates with cross-functional teams, advises on validation matters, and ensures compliance, contributing to process improvement and audit readiness.

Must Have

• Drafting and reviewing validation protocols (validation masterplans, design documents, IQ, OQ)
• Complete understanding of BMS policies and procedures for computer software validation
• Close collaboration with cross-functional subject matter experts
• Actively participate in analyzing and addressing process deficiencies
• Compliance with local and global SOPs during qualifications
• Compliance with (Project) Change Management Procedure
• Audit and Operational readiness for the site
• Bachelor’s in engineering, IT, Science field or equivalent
• Minimum 5+ year’s relevant industry experience
• Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment
• Understanding of supply chain, manufacturing and quality domains and supporting technology (MES, LIMS, QMS, ERP, Process Automation, Historians, Benchtop systems)
• Working knowledge of regulatory requirements (GxP, GAMP, SDLC, 21CFR part 11, EudraLex Annex 11)
• Knowledge of good documentation practices
• Demonstrated success in a high-performing, business results-driven environment

Good to Have

• Prior Cell Therapy experience

Perks & Benefits

• Competitive benefits, services and programs
• Opportunities to grow and thrive
• Supportive culture
• Global participation in clinical trials
• Benefits and Wellbeing (Global platform and benefits for physical, mental, financial and social wellbeing)
• Recognition (Global platform to reward your achievements)
• Generous time off to rest and recharge
• Best-in-class health benefits
• 8 People & Business Resource Groups
• Reasonable workplace accommodations/adjustments for people with disabilities

Job description

Life at BMS

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.

The Manager BI&T Computer Software Validation (CSV) is responsible for drafting and reviewing validation protocols, including validation masterplans, design documents, process and instrumentation drawings, IQ, OQ, and related protocols. This role requires a complete understanding of BMS policies and procedures for computer software validation and involves close collaboration with cross-functional subject matter experts to develop and implement validation methodologies for IT systems at the Leiden site. The CSV manager actively participates with other groups to analyze and address process deficiencies, working collaboratively with peers across departments and quality teams. As a validation subject matter expert in the BI&T department, the manager contributes to multi-functional teams, advises personnel on validation matters, and defends validation work before regulatory agencies and auditors. The CSV manager also provides expertise and guidance to management, peers, and junior professionals.

Key Responsibilities

• CSV Manager within the Leiden BI&T department.
• Responsible for compliance with local and global SOPs during qualifications.
• Compliance with (Project) Change Management Procedure and Change Management drafting, review and approval.
• Audit and Operational readiness for the site.
• Change Management during qualification and sustaining.
• Other duties as assigned by Senior Manager, BI&T Quality and Compliance.

Qualifications & Experience

• Bachelor’s in engineering, IT, Science field or equivalent
• Minimum 5+ year’s 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-Onsite

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.

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 reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo\-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.