Sr. Specialist, Supplier Quality
Bristol Myers SquibbAbout the role
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 o
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