Senior Manager, GxP IT Quality Assurance & E-Compliance F

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 rich in diversity. 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 .

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. $148,526/yr – $192,170/yr.

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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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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility 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: https://careers.bms.com/california-residents/

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