Senior manager quality systems and process owner

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 .

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 Systems, Investigations and CAPA Process Owner is responsible for ownership and oversight of the Investigations and CAPA quality systems, per established local and global standards. This local process owner is accountable for the overall compliance and performance of the Investigations and CAPA processes as they apply to the site level, including periodic assessments of process performance and continuous improvement opportunities.

Shifts Available:

TBD

Responsibilities:

• Review and approve complex site investigations and CAPA associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.

• Ensure Investigations and associated notifications to management (NTM) and CAPA are robust and adequately address requirements and risks

• Own and maintain the site Investigations and CAPA systems, including:

• Assuring local compliance with applicable BMS Policies, Guidelines, and Directives and ensures consistency with site and global procedures and/or specifications.

• Leading the Investigation and CAPA Review Boards

• Identifying appropriate measures for quality system health and collecting, analyzing, and communicating data to stakeholders

• Utilizing data to identify areas for improvement and driving improvement initiatives related to investigations and CAPA

• Setting clear quality expectations for the quality system and providing the tools, training, and support required for users to succeed

• Serving as site champion and representative for global investigations, CAPA, NTM, and complaints initiatives, engaging appropriate stakeholders, as applicable

• Identify improvement opportunities and drive execution of site continuous improvement goals and projects related to investigations and CAPA

• Influence effective and efficient quality system programs throughout the site

• Act as subject matter expert and present program overview and related topics during audits.

• Maintain compliance with assigned learning plan.

• Act as Subject Matter Expert of for investigations, CAPA, and NTM programs and provide guidance/ coaching to users

• 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.

Knowledge, Skills, Abilities:

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines

• Proficient computer skills, with knowledge of digital tools such as MS Office, and ability to learn and work with new software applications

• Advanced ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed actions

• Ability to critically review reports, interpret results, and assess and challenge technical conclusions consistent with Quality Risk Management principles

• Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy

• Ability to work in a fast-paced team environment and lead team and cross-functional stakeholders through changing priorities.

• Ability to think strategically, meet deadlines and prioritize work

• Ability to independently work across and influence cross-functional groups and network teams to ensure requirements are met

• Ability to motivate and foster a positive team environment

• Confident in making decisions, able to anticipate Quality issues and proactively solve problems

• Curious, with an 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 quality system experience including demonstrated experience with Deviations and Investigations. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

• Demonstrated proficiency with electronic system and databases

BMSCART

#LI-ONSITE

GPS_2025

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.

Compensation Overview:

Devens - MA - US: $138,670 - $168,034

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. 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

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.

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 [email protected] . 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:

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

Company: Bristol-Myers Squibb

Req Number: R1596146

Updated: 2025-10-28 05:10:11.124 UTC

Location: Devens-MA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.