Senior Specialist, Quality Assurance Shop Floor, Cell Therapy

Position Summary The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The role oversees and partners with operational areas to ensure compliance with Bristol‑Myers Squibb policies, standards, procedures, and Global cGMP. This position reports to the Shift Manager, Quality Assurance Shop Floor and works a rotating 2‑3‑2 Panama schedule (6 AM to 6 PM) Day shift. Key Responsibilities Provide Quality on‑the‑floor oversight to Manufacturing/QC/Warehouse/Packout operations; identify departures from approved procedures and respond to complex issues independently, escalating critical issues to management. Perform and document operational verification per approved procedures. Develop, review, and/or approve temporary and non‑routine procedures for event response. Observe manufacturing operations and identify departures from clean‑room behaviors and aseptic techniques. Provide quality oversight to non‑routine maintenance work; review and approve return‑to‑service plans. Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans. Own shift actions for departmental programs and propose improvements to programs. Participate in Gemba walks. Review manufacturing or testing records to ensure compliance with approved procedures; communicate and resolve discrepancies independently and escalating as required. Author, review, and approve procedural documents. Maintain compliance with assigned learning plan; provide guidance and training for QA personnel. Own training curriculum and content (as required). Present individual topics during audits as needed. Independently assess discrepancies for entry into the quality system and approve deviations as applicable. Serve as quality subject matter expert for risk assessments, change controls, etc. Lead meetings and represent function at cross‑functional meetings. Share data and knowledge within and across teams; build and maintain strong relationships with partner functions. Prioritize and assign tasks for the team. Qualifications Ability to research, understand, interpret, and apply internal policies and regulatory guidelines. Proficient computer skills with knowledge of digital tools such as MS Office; ability to learn and work with new software applications. Ability to interpret data and results; understand complex problems with multiple variables and articulate practical solutions. Excellent written and verbal skills; ability to present technical data effectively based on target audience. Ability to work in a fast‑paced team environment and lead peers through changing priorities. Detail‑oriented and task‑focused with ability to meet deadlines and support work prioritization. Ability to negotiate and influence to craft mutually beneficial solutions. Ability to motivate and foster a positive team environment. Strong decision‑making ability and creative thinking while maintaining compliance and quality. Pioneering mindset and ability to create innovative solutions. Education: Bachelor’s degree in STEM field preferred; high‑school diploma or associate’s degree with equivalent combination of education and work experience may be considered. 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience; experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Demonstrated experience with quality management systems. Demonstrated experience with electronic systems and databases such as MES, ERP, etc. Compensation Overview Devens – MA – US: $89,780 – $108,789 annually. The starting compensation range is for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities, subject to eligibility, may be available. Final compensation is based on demonstrated experience. Benefits Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs. Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work‑Life Benefits Paid Time Off for US Exempt Employees: flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio). Paid Time Off for Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non‑Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. Additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs. Annual Global Shutdown between Christmas and New Year’s Day. Occupancy Requirements BMS has an occupancy structure that determines where an employee is required to conduct their work. Roles may be site‑essential (100% onsite), site‑by‑design (eligible for hybrid with at least 50% onsite), field‑based, or remote‑by‑design. Equal Employment Opportunity Statement BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. Applicants can request accommodations prior to accepting a job offer. For more information, visit careers.bms.com/eeo-accessibility. Candidate rights: BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws. If you live in or expect to work from Los Angeles County if hired for this position, please visit Data protection: We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Contact & Additional Information If you believe that the job posting is missing information required by local law or is incorrect, please contact BMS at View email address on click.appcast.io. Please provide the Job Title and Requisition number so we can review. 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