Senior Specialist, QA Technical Operations

Working with Us: Challenging, meaningful, and life‑changing. At Bristol Myers Squibb, you’ll find uniquely interesting work every day—whether optimizing production lines or advancing breakthroughs in cell therapy. You’ll grow and thrive through opportunities unlike most, alongside high‑achieving teams and take your career farther than you thought possible. Position Summary Support the Devens site by reviewing and approving investigations and change controls. Provide quality oversight and support for Technology Transfer, Automation, Cell Bank Disposition, Validation, Manufacturing Science & Technology, Master Data and Site Engineering programs. Ensure manufactured products meet all applicable regulations and guidelines, and assist in preparing for and hosting regulatory audits. Key Responsibilities Provide quality oversight to technical transfer sub‑teams and review/approve technology transfer documentation. Maintain operating procedures for the site Quality Assurance programs to ensure high‑quality materials are produced. Provide floor support to the manufacturing process as a person‑in‑plant function. Review and approve Quality, Manufacturing, and Material Specifications SOPs, documents, and batch records. Oversee quality walkthroughs for shutdown and inspection readiness activities, ensuring compliance with site and corporate procedures. Contribute to and support the site team preparing for, hosting, and responding to regulatory inspections and audits. Establish and communicate performance objectives for Quality Assurance staff, enforce performance measures, provide coaching, and foster collaboration across site departments. Provide quality review and approval of investigation records, CAPA records, change management, automation changes, and document updates/creations. Identify and implement changes to enhance long‑term departmental goals and drive continuous improvement. Qualifications & Experience B.S. in science, engineering, biochemistry, or a related discipline (or equivalent). Preferred but not required. Minimum of 5 years of experience in a regulated environment with at least 3 years focused on product quality. Knowledge of biotech bulk and finished product manufacturing is highly desirable. Extensive knowledge of U.S. and E.U. cGMP regulations and guidance. Knowledge of Quality Risk Management principles is preferred. Experience with electronic systems such as SAP, LIMS, Infinity (Veeva Vault), LES, Maximo, Vault, or Syncade is desirable. Demonstrated experience working in a team‑based environment with a diverse group of people. Compensation Overview Devens – MA – US: $81,160 – $98,344. The starting compensation range is for a full‑time employee. Additional incentive cash and stock opportunities may be available based on eligibility. Final pay will be determined by experience and demonstrated competence. 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. Paid Time Off and Work‑Life Benefits US Exempt Employees: flexible, unlimited time off with manager approval; 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio). 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. Eligibility may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day. All global employees who are actively employed at and paid directly by BMS at the end of the calendar year are eligible for the Global Shutdown. On‑Site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. Site‑essential roles require 100% of shifts onsite; site‑by‑design roles may be eligible for a hybrid model with at least 50% onsite. Field‑based and remote‑by‑design roles require travel to customers, patients, or business partners as an essential job function. Supporting People With Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support. Applicants may request accommodations prior to accepting a job offer. For assistance, contact View email address on click.appcast.io or visit careers.bms.com/eeo-accessibility for our Equal Employment Opportunity statement. Candidate Rights BMS will consider qualified applicants with arrest and conviction records pursuant to applicable laws in your area. 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. #J-18808-Ljbffr Bristol Myers Squibb EU Policy