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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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Senior Manager, Quality Engineer is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer. The Senior Manager, Quality Engineering is responsible for quality oversight.

Shifts Available:

TBD

Responsibilities:

Act as project lead for QA validation / engineering oversight.Managing deliverable timelines, and business process improvements.QE lead of the review, approval, and quality decision making for commissioning and qualification lifecycle documentation associated with large and/or complex facility, equipment, or utility projects, including but not limited to system/component impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, etc.QE lead of the review, approval, and quality decision making for computer systems validation lifecycle documentation associated with manufacturing site digital systems, including but not limited to system classification, user requirements, functional specifications, installation qualification, operational qualification / system testing, user acceptance testing, performance qualification, periodic review, etc.QE lead of the review, approval, and quality decision making for process validation lifecycle documentation associated with manufacturing site processes, including but not limited to engineering run, process validation, mixing studies, aseptic process simulation, process performance qualification, process data reviews, continued process verification, etc.Act as SME and/or Quality reviewer/approver for complex risk assessments, data integrity assessments, and technical reports supporting the manufacturing process and supporting systems.May perform routine quality review/approval activities associated with equipment/system onboarding and statusRepresent Quality on large capital projects or technology transfer initiatives and review/approve complex validation or master transfer plans.Identifies improvement opportunities and drives execution of site/cross-functional continuous improvement goals and projects, including sharing best practices, and harmonizationMay review and approve or provide impact assessment for complex site and global change controls.Support internal and external inspections as required. Participate in the preparation and execution corrective and preventative actions related to inspection findings.Maintain compliance with assigned learning plan. Support development of training content.Act as validation Subject Matter Expert in multiple validation disciplines and provide guidance/ coaching to less experienced staff and cross-functional partners with atypical events during qualification.Lead meetings and represent function at cross functional and network meetings.Share data/ knowledge within and across site and network.Build & maintain strong relationships with partner functions and global counterparts. Influence network teams on site behalf.

Knowledge and Skills:

Ability to research, understand, interpret and apply internal policies and regulatory guidelinesProficient computer skills with knowledge of several digital tools like MS Office, etc. and ability to learn and work with new software applicationsAdvanced ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.Advanced ability to critically review investigation reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principlesExcellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracyAbility to work in a fast-paced team environment and lead team and cross-functional peers through changing priorities.Ability to think strategically, meet deadlines and support work prioritization for team.Able to independently work across and influence cross-functional groups and teams to ensure requirements are met.Ability to motivate and foster a positive cross-functional team environmentConfident in making decisions, able to anticipate Quality issues and proactively solve critical and/or complex problems.Curious, with the ability to think critically to create innovative solutions.

Basic Requirements:

Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.8+ years of experience in a regulated industry, preferably with 4+  year of  [insert validation discipline]  experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.Demonstrated proficiency with electronic validation documentation systems.

The starting compensation for this job is a range from $130,700 - $158,400, plus incentive cash and stock opportunities (based on eligibility).

           

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 https://careers.bms.com/life-at-bms/.

           

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 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 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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