Senior Manager, Qualified Person

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. At Bristol Myers Squibb, we are united by a single purpose: transforming patients' lives through science. As part of our Pharma QP Operations organisation, you will play a critical role in ensuring the quality, safety and compliance of medicines supplied to patients across Europe and global markets. We are seeking an experienced Senior Manager, Qualified Person to join our team on a 12-month fixed-term contract. Reporting to the Director, Pharma QP Operations, this role offers the opportunity to provide independent quality oversight, certify commercial pharmaceutical products and influence strategic quality decisions across a diverse and global manufacturing network. ## The Role As a named EU Qualified Person, you will be responsible for the certification of pharmaceutical products for EU/EEA and Rest of World markets in accordance with GMP, applicable legislation and marketing authorisations. You will work closely with internal manufacturing sites, external manufacturing partners, supply chain, regulatory affairs and quality organisations to ensure uninterrupted supply of compliant medicines to patients. This 12-month assignment provides a unique opportunity to apply your QP expertise across a complex and global supply network while supporting product launches, strategic business initiatives and continuous improvement within the QP organisation. ## Key Responsibilities * Perform EU Qualified Person duties in accordance with Directive 2001/83/EC and Annex 16 requirements for EU/EEA and global markets. * Provide expert guidance to Quality Operations teams supporting batch certification activities. * Support investigations through FIT, FIRM and Product Review Committee processes. * Partner with launch excellence, supply chain and manufacturing teams to support new product introductions and market launches. * Participate in regulatory inspections, corporate audits, recalls and competent authority notifications. * Maintain current knowledge of GMP, regulatory requirements and manufacturing technologies through ongoing professional development. ## What You'll Bring Qualifications * EU/EEA QP eligibility meeting the educational requirements of Article 49 of Directive 2001/83/EC. * MSc (or equivalent) in a scientific, technical or related discipline. Experience * Significant experience operating in a regulated pharmaceutical manufacturing environment. * Demonstrated experience as an actively releasing Qualified Person. * Strong knowledge of GMP requirements, pharmaceutical manufacturing processes and regulatory compliance. * Proven ability to make independent, risk-based quality decisions and manage complex stakeholder relationships. * Strong leadership, communication and influencing skills. ## Why Join Bristol Myers Squibb? This role offers the opportunity to make a meaningful impact on patient supply while working alongside a highly experienced global QP organisation. You'll contribute to the certification and release of innovative medicines, support new product launches and collaborate with manufacturing and quality leaders across the BMS network. If you're an experienced Qualified Person looking for a challenging 12-month opportunity to apply your expertise in a global organisation dedicated to patients, we'd love to hear from you. #LI- Hybrid We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. How We Work Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act. 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