Senior Specialist, QA Technical Operations

R1603597: Senior Specialist, QA Technical Operations 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. Position Summary Support Devens site through review and approval of investigations and change controls. Provide Quality oversight and support for Technology Transfer, Automation, Cell Bank Disposition, Validation, Manufacturing Science and Technology, Master Data and Site Engineering programs. Assure the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for and hosting of regulatory audits. Key Responsibilities Supports and provides quality oversight to technical transfer sub-teams and the review and approval of technology transfer documentation Maintains operating procedures for the site Quality Assurance programs to ensure consistent, high-quality materials are produced. Provides floor support to the manufacturing process as needed in a person-in-plant function. Performs review and approval of Quality, Manufacturing, and Material Specifications SOPs, documents, and batch records. Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management is in compliance with site and corporate procedures. Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products. Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams. Establish and communicates performance objectives for Quality Assurance staff that are consistent with the business' unit goals, Quality and Technical Operations objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments. Provide Quality review and approval of investigation records, CAPA records, change management, automation changes, and applicable document updates/creations. Provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement. Qualifications & Experience Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 5 years of relevant 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 US and EU cGMP regulations and guidance. Knowledge of Quality Risk Management principles preferred. Knowledge of electronic systems including any of the following: SAP, LIMS, Infinity (Veeva Vault), LES, Maximo, Vault and Syncade desirable. 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(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. Benefits Health Coverage: Medical, pharmacy, dental and vision care. Wellbeing Support: Programs such as 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. Supporting People With Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations or adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation or adjustment prior to accepting a job offer. If you require reasonable accommodations or adjustments in completing this application or in any part of the recruitment process, direct your inquiries to View email address on click.appcast.io. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. #J-18808-Ljbffr Bristol Myers Squibb