Associate Director, Qualified Person (QP)

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 BMS Biologics is seeking to recruit an Associate Director responsible for Finished Drug Product (FDP) certification of biological products for the EU/EEA and ROW markets. The Associate Director will operate with significant autonomy and will be responsible for QP batch certification across two Manufacturing Import Authorizations (MIAs), ensuring consistent, risk-based decision-making and alignment of quality standards across internal and external manufacturing sites. The Associate Director will work independently on behalf of the QP operations organization to provide conceptual and practical expertise in QP requirements and ways of working. They will use best practices and knowledge of the regulatory landscape to improve products/services or processes across the business. Typically, work will involve resolution of complex problems or problems where precedent may not exist. The individual will represent the QP team on cross-functional projects and provide leadership in the implementation, management, and execution of the Quality Management System for the relevant entity, ensuring product quality and compliance with applicable regulatory and corporate requirements across EU/EEA and ROW markets. Where required, the Associate Director will manage Qualified Persons and other quality professionals, providing support and guidance to colleagues. Please note that there are two openings available for this role under this job posting.

Certification of finished product batches for EU/EEA and ROW markets in accordance with Article 51 of Directive 2001/83/EC, confirming that each batch has been manufactured and checked in compliance with the Marketing Authorization, EU GMP requirements, applicable national legislation, and other relevant legal requirements prior to release. Perform release duties on behalf of the registered site of release for products not listed on the MIA under the remit of the QP team, as needed. Act as the QP primary contact for product/brand-related queries, as required. Represent the relevant Qualified Persons team in a cross-functional capacity, taking the lead from a QP perspective on company-wide projects and initiatives. Build strong, collaborative relationships with Manufacturing, Quality, Regulatory, and Supply Chain to enable timely and compliant product disposition across global markets. Chair or participate in product disposition governance forums and provide independent quality-based recommendations regarding batch release and market supply decisions. Collaborate with launch excellence and other functional areas to support new product introductions and new market launches. Participate in the product recall process and/or Health Authority notification processes, as required. Continually maintain familiarity with the manufacturing and testing requirements specified in the Marketing Authorisation, national legislation, or cGMPs for all products under their remit as per the MIA. As required, manage a team of Qualified Persons and/or other Quality professionals, including