Sr. Manager, Computerized Systems Validation and IT Compliance

Posted on: 07-05-2025

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: .
 
 Sr. Manager, Computerized Systems Validation and IT Compliance, Bristol-Myers Squibb Company, Bothell, WA. Lead development of the computerized systems validation strategy, including stage gate deliverables. Plan and manage assigned CSV (Computerized Systems Validation) projects; manage author, review and/or approve processes for applicable CSV lifecycle documentation. Ensure the validation of computerized systems used across GXP (Good x Practice) operations is conducted in compliance with applicable regulatory requirements and internal procedures. Partner with Business Owners, IT, and QA to ensure a compliant management of the computerized systems lifecycle. Act as subject matter expert for CSV and IT Quality during regulatory inspections. Conduct impact assessments for changes impacting validated computerized systems. Maintain the inventory of all computerized systems and requalification / revalidation schedules. Oversee internal validation employees and external, their contractors, including training, assignment of projects and ensuring the timely completion of their deliverables. Track CSV deliverables and provide periodic progress reports to upper management and stakeholder. Manage department metrics reporting linked to regulatory compliance and Quality Events, including Deviations, CAPAs, Change Requests, Training, and completion of applicable procedural requirements. Partner with Quality, and Business / Technical Owners on continuous improvement efforts to reduce or eliminate adverse trends related to Quality Events impactful to IT. Participate in governance boards, acting as the IT representative for regulatory and procedural compliance using experience with Quality Systems (Deviations, CAPAs, Change Requests, SOPs) related activities, with a demonstrated understanding of electronic records / signatures and application of the ALCOA+ principles of data integrity. Support regulatory inspections as a SME (subject matter expert) and manage supporting contract resources. Perform and lead investigations and root cause analyses for Quality Event deviations related to IT systems. Author and contribute content, review and approve applicable Quality Systems records, including Deviations, CAPAs, Change Requests, and SOPs.
 
 40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $154,500 - $185,960/yr. Standard company benefits.
 
 MINIMUM REQUIREMENTS:
 
Master’s degree or foreign equivalent degree in Chemical Engineering or a related field, and five (5) years of post-baccalaureate experience.
 
Must have experience with Six Sigma, quality system, computerized system, CSV, technical writing, and quality management.
 
The required skills do not need to be maintained over the full term of required experience.
 
Six Sigma Green Belt certificate is required.
 
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
 
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.
 
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
 
*** If BMS Careers Site link is not copying and pasting correctly, please add manually using the following address: .
 
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.
 
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 . Visit to access our complete Equal Employment Opportunity statement.
 
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
 
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:
 
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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Company: Bristol-Myers Squibb

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