Associate Director, Qualified Person (QP)

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. Position 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. Key Responsibilities 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 coaching, development and performance management, where applicable. Provide quality and compliance guidance on critical and major quality matters. Review and approve quality documentation (e.g., deviations, CAPAs, change controls, customer complaint investigations), ensuring appropriate assessment of impact on product quality and patient safety. Develop and maintain QP oversight procedures/processes for both internal and CMO sites to continually support the QP function in line with Annex 16 of the EU GMP guide. Perform CMO site visits as required to provide QP oversight, assess compliance, and support effective quality and supply governance. Act as a key SME during regulatory inspections and corporate audits, demonstrating QP accountability and readiness (e.g., HPRA, IGJ, EMA, FDA, PMDA, Health Canada as applicable). Identify and mitigate risk within complex, multi-site and global supply chains, including importation and third-party manufacturing. Develop and mentor talent, strengthening capability within the QP function. Leverage digital systems and data analytics to inform QP decision-making, enhance oversight, and support performance management. Provide expert guidance on sterility assurance topics, including sterile manufacturing processes, aseptic processing, contamination control strategy, and environmental monitoring. Undergo continuous professional development, including self-study, site visits, and internal and external training courses, to maintain up-to-date knowledge of pharmaceutical legislation and industry practice. Core competencies include strong decision making, leadership, communication, strategic thinking, coaching, collaboration and problem-solving skills. Qualifications & Experience Educated to a degree level in science, engineering or related discipline with a minimum of 12 years’ experience in the biopharmaceutical/pharmaceutical industry. Eligible to act as Qualified Person in accordance with the EU Guide to Good Manufacturing Practice, as defined in Article 51 of Directive 2001/83/EC, with a minimum of 5 years’ experience as an acting QP named on a Manufacturer’s Authorisation. Experience in the manufacture of biological products and/or aseptic manufacturing would be beneficial. Demonstrated broad technical expertise across the product lifecycle, including drug substance and drug product manufacture, packaging operations, analytical testing, validation, technology transfer, and in-market quality. #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. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit