Supplier Quality Senior Specialist

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 .

Summary The Supplier Quality Senior Specialist is responsible for work which supports the GMP/GDP Vendor and Material Management programs at the Devens Biologics site. This includes vendor qualification and management, material qualification and management, change management and supplier related non-conformance reporting and resolution.

Qualification and management of GMP/GDP vendors, including assessment of vendors, creation and revision of Quality agreements and maintenance of the Approved Vendor List.   Lifecycle management of starting materials used for the manufacture of drug substance, including material qualification and requalification, reduced testing, and direct dispense. Assessment of supplier change notifications (SCN) and identification and completion of required actions within the BMS change management system. Assists with internal or external deviations, Supplier Corrective Action Requests (SCAR), and CAPA associated with nonconforming materials or services provided by vendors. Performs review of documents including standard operation procedures, technical documents / reports, agreements, qualifications, and forms. Executes oversight of on-site service vendors throughout the facilitiy in collaboration with the business owners and QA Operations. Exercises sound decision making within generally defined processes to select methods for resolving routine work. Identifes risks to Quality and business continuity and applies appropriate notification to management as appropriate. Collaborates with cross-functional site and network stakeholders with a concise and solution oriented approach. May represent the team on cross-functional projects and initiatives related to suppliers and materials. May participate in external audits as a support team member under supervision of the lead auditor. Qualifications & Experience Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, or related discipline, or combination of education, experience and training. A minimum of 4 years direct experience in a regulated, biopharmaceutical environment or similar, is required. Practical knowledge of US and EU cGMP regulations and guidance and ISO standards. Familiarity with common electronic systems such as SAP, Veeva, and Syncade. Demonstrated work experience that reflects attention to detail, personal accountability, and a collaborative mindset that delivers results. Excellent written and oral communication skills are necessary. 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.

Overview: Devens - MA - US: $89,530 - $108,490
 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