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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.

Senior Manager, GxP IT Quality Assurance & E-Compliance, Bristol-Myers Squibb Company, New Brunswick, NJ. Oversee computer system validation and software development to assure regulatory compliance across the end-to-end product lifecycle (Research & Development). Ensure the research and development is conformance to current GxPs, guidance documents, applicable industry accepted standards and requirements. Review and approve the key computer software life cycle (SLC) deliverables. oversee key software development life cycle (SDLC) process such as problem, incident, change, release, etc. Ensure adequate and timely regulatory compliance support. Report on key metrics across the ITQA tower. Oversee the qualification BMS infrastructure that support regulated business applications. Support on regulated system Data Migrations, Data Archival and Retirements. Provide active support during regulatory agency and third-party inspections. Research new technologies, understand existing processes, and reference recognized standards and frameworks. Recruit, manage and coach beeline contractors and third-party vendors on BMS Computer System Validation (CSV) procedures to support computer system validation and software development.

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m.

MINIMUM REQUIREMENTS:

Bachelor’s degree or foreign equivalent degree in Computer Science, Computer Engineering or related field, and five (5) years of post-baccalaureate, progressive, related experience.

Must have experience with/in the following:

• Health Authority (HA) Regulations;
• Computer Software Assurance (CSA);
• Artificial Intelligence (AI)/Machine Learning (ML) relevant to IT Quality function;
• Quality Management Systems; and
• Quality Risk Management Concept.

The skills, knowledge and/or experience do not need to be maintained over the full term of experience required.

May work five (5) days per two (2) weeks within normal commuting distance of New Brunswick, NJ.

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.

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