Senior Specialist, Quality Systems, LPO

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.

The Senior Specialist for Quality Systems at the S-12 Cell Therapy Manufacturing is responsible for the oversight and management of the Corrective and Preventive Action (CAPA), Supplier Corrective Action Request (SCAR), Change Control, Deviation and complaints processes. In this role, the incumbent will serve as local process owner (LPO) for the CAPA, SCAR, Change Control, Deviation, Complaint modules and the associated governing local procedures and supporting processes.This highly visible position requires cross-functional collaboration and has a direct impact on site quality performance and continuous improvement initiatives.

Key Responsibilities:

• Manages Change Control, CAPA, Deviation, SCAR, and Complaint Quality Systems for all GMP activities and works with responsible cross functional areas ensure timely completion.
• Run the Change Control Process, CAPA, Deviation Review Board, generate meeting minutes, follow up on action items and facilitate resolution when required
• Compiles applicable process metrics, identifies trends and escalates accordingly
• SME support during internal and health authority inspections of facility
• Communicates effectively with cross functional stakeholders on matters related to change control process
• Review and approve CAPA, and Change Controls
• Supports Quality Systems harmonization efforts.
• Performs other tasks as assigned by manager.

Qualifications & Experience:

• College or university degree required.
• 4-7 years of experience in cell therapy, pharmaceutical or related industry
• An equivalent combination of education and experience may substitute

• Must have experience with cGMP manufacturing, Quality, and Compliance.
• Must have strong authorship and be able to critically evaluate change controls and generate technical conclusions consistent with Quality risk management principles.
• Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues.
• Must understand continuous improvement and be able improve the compliance and efficiency of the quality system.
• Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
• Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.
• Requires moderate direction to complete more complex tasks
• Comfortable providing input/guidance to others within the department and across the organization in change control technical writing.
• Propose solutions for issues and work with management to resolve.
• Comfortable providing training/guidance to system users as needed, and in instructor-led settings.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to support internal and health authority inspections of facility.

LI-Onsite

BMSCART

VETERAN

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:

Summit West - NJ - US: $83,900 - $101,671


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 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.

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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