Sr. Specialist, Supplier Quality

Job description

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. Key Responsibilities The position holder is responsible and accountable for the tasks given below (non-exhaustive list): Quality oversight of the activities and services provided by suppliers: Serves as a single point of QA contact for indirect suppliers supporting CT manufacturing sites. Assists with supplier qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities. Initiate and Manage Supplier Quality risk assessments. Create / negotiate and maintain Supplier Quality Agreements. Work closely with the suppliers and involve SMEs to ensure proper and timely resolution of SCARs, Deviations, Complaint investigations and CAPAs; ensures properly documented per BMS procedures. Evaluate and communicate supplier quality related changes, ensuring assessment per BMS change control procedures and documented in a timely fashion. Participate in BMS audits at suppliers, as needed. Travel could be up to 10%. Coordinate / Support Supplier Quality Vendor Changes and Supplier Issue, as well as the approval process for new suppliers. Collect supplier quality documentation necessary to support regulatory submissions. Hold appropriate periodic quality meetings with supplier representatives, as needed. Hold or actively participate in joint periodic meetings with stakeholders. Initiate and assess Change control, complaints, deviations/OOS and CAPA management in electronic system - e.g. support and quality guidance to record owners, follow up until completion, owner role as appropriate, closure in a timely manner. Partner with stakeholders to assess overall supplier performance, including identifying product-specific quality and compliance risks and develop mitigation plans based on a risk-based approach. Provide timely support and necessary information to QA colleagues and Quality/Supply Chain Management as required. Act as representation for Quality Operations as required, escalate critical issues to Management as appropriate. Author necessary quality system documents; review and update procedures for BMS Quality Management System per process ownerships. In partnership with the CoEx sponsor, define and execute the short‑ and long‑term strategy for the assigned Center of Excellence, ensuring alignment with global supplier quality objectives. Serve as the CoEx subject matter expert, driving initiatives, continuous improvement, KPI performance, and accountability for effective adoption of CoEx processes across the enterprise. Create detailed plans of the CoEx activities using Project Management tools. Support Health Authority inspections and audits of the site, act as QA representative (SME) for functional area relevant topics. Participate as QA representative to internal work streams, projects and improvement initiatives. Qualifications & Experience BS or MS or equivalent education in science, or related fields. Minimum 3-5 years of experience in a pharmaceutical/biopharmaceutical environment including previous QA experience – e.g. QA compliance role, Supplier Quality oversight Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines. Experience in Supplier Quality oversight. Knowledge of cell therapy manufacturing processes and testing is a plus. Good knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes Experience with performing/participating in risk assessment exercises. Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR-PQR. Excellent investigational and QA problem solving skills – able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy; able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas and to a deeper level in the specific job function; and must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles. Analytical mindset – able to assess vendors quality core processes to ensure compliance with relevant guidelines and procedures; able to identify acceptable mitigation actions; able to recognize quality risks and develop contingency plans; able to assess, establish and implement new quality processes both internally and in partnership with assigned vendors. Able to author resulting procedures and tools; and able to recognize patterns in reported data and communicate strategic solutions to stake holders cross-functionally. Quality performance / continuous improvement oriented – able to create and maintain meaningful metrics for assigned activities; able to recognize trends in product data and results; and able to assess and recommend improvement measures to processes; able to drive implementation accordingly. Good understanding of batch disposition principles, aligned with QP concept and associated duties including liaison with Health Authorities. Skilled in planning and organizing, building relationships, innovation management and resource allocation. Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide. Team spirit. Action-oriented and customer-focused. Negotiation and persuasion skills. Good knowledge of most common office software. Good verbal and written communication skills in English. Travel: This position requires up to 10% of travel #BMSBL #LI-Hybrid 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: Devens - MA - US: $105,330 - $127,638 Madison - Giralda - NJ - US: $98,440 - $119,284 New Brunswick - NJ - US: $98,440 - $119,284 Princeton - NJ - US: $98,440 - $119,284 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 in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Li