Senior Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm)

Position Summary The Quality Assurance Shop Floor team is responsible for 24x7 quality collaboration and oversight of site operations, including manufacturing, quality control laboratories, and warehouse operations. This position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. As a QA Shop Floor Senior Specialist, you will serve as a Quality Representative interacting with manufacturing, supply chain, quality control and other supporting functions. You are accountable for quality decision-making related to unexpected events on the production floor, deviation triage and determination, and will participate in cross-functional triage meetings. You will review and approve GxP records, including procedures, batch records, deviations, and support deviation approval, alarm approval, and other Quality System Records as requested. Key Responsibilities Provide quality oversight to manufacturing, QC, warehouse and 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, or approve temporary and non‑routine procedures for event response. Observe manufacturing operations and identify departures from clean-room behaviors and aseptic techniques. Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans. Own actions for departmental programs and propose improvements to programs. Participate in Gemba walks. Communicate and resolve discrepancies independently and elevate as required. Author, review, and approve procedural documents. Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel; may own training curriculum and content, and may present individual topics during audits as needed. Independently assess discrepancies for entry into 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 team; build and maintain strong relationships with partner functions. Prioritize and assign tasks for the team. Periodically observe operations on the floor, proactively identify risks and drive improvements. Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals. Function as a project manager able to influence others based on time and task commitments, organising and running meetings. Obtain access to and develop as an SME for various electronic systems utilised by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.). Be familiar with GMP‑related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting. Act as a champion for quality culture and learning, sharing data and knowledge across teams. Qualifications & Experience Ability to research, understand, interpret and apply internal SOPs, 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. Ability to interpret data and results, understand complex problems with multiple variables, and articulate practical solutions. Excellent written and verbal skills, and 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 prioritisation. Ability to negotiate and influence to craft mutually beneficial solutions. Ability to motivate and foster a positive team environment. Exhibit strong decision‑making ability and think creatively while maintaining compliance and quality. Pioneering mindset and ability to create innovative solutions. Demonstrated experience with quality management systems for handling records such as change control, product complaints, deviations, investigations and CAPA management. Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. Bachelor’s degree in a STEM field preferred; high school diploma or associate’s degree with equivalent education and work experience may be considered. 4+ years of relevant cGMP experience, preferably with at least 1 year of manufacturing site experience. Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Demonstrated experience with quality management systems. Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS), Manufacturing Execution Systems (MES) for electronic batch records, Enterprise Resource Planning (ERP) such as SAP, laboratory information management systems, or electronic logbooks/forms. Compensation Overview Location: Devens, MA, US. Salary range: $89,780 – $108,789 for a full-time employee. Additional incentive cash and stock opportunities may be available. Final pay will be determined based on demonstrated experience. Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). 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, flexible time off with manager approval, national holidays, optional holidays, unlimited paid sick time, volunteer days, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and annual global shutdown. Equal Employment Opportunity & Accommodations BMS is committed to equal opportunity employment and to ensuring people with disabilities can excel through a transparent recruitment process. For assistance with accommodations, contact View email address on click.appcast.io. Visit careers.bms.com/eeo-accessibility for the full Equal Employment Opportunity statement. #J-18808-Ljbffr Bristol-Myers Squibb