Senior Manager, PV Process Quality Lead

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. # About the Role At Bristol Myers Squibb, we are committed to transforming patients' lives through science. Our Patient Safety Quality Management (SQM) team sits at the heart of that mission — ensuring our pharmacovigilance systems are world-class, inspection-ready, and continuously improving. We are looking for a seasoned quality and compliance leader to drive strategic GVP deviation management, CAPA oversight, and quality risk management across a global, matrixed organization. If you thrive at the intersection of science, compliance, and leadership — this role is for you. # What You Will Do * Lead the strategic investigation and closure of high-impact GVP deviations, shaping remediation priorities and organizational risk management at a senior level * Drive enterprise-wide CAPA management and quality risk initiatives, ensuring full alignment with global regulatory requirements * Deliver advanced root cause analyses and trend intelligence, translating complex data into persuasive recommendations for senior leadership * Maintain and evolve QMS documentation, setting policy standards for deviation management, management notification, and CAPA processes * Build and champion cross-functional partnerships across R&D and BMS, embedding a consistent culture of quality and continuous improvement * Serve as the internal authority for global Deviations and CAPA networks, influencing enterprise IT systems and processes to meet GVP requirements * Lead the Pharmacovigilance Safety Quality Forum, reporting quality events, audit CAPAs, and risk management findings to senior Patient Safety leadership * Oversee the accuracy and strategic use of deviation and CAPA data within the Pharmacovigilance System Master File (PSMF) * Monitor external intelligence — regulations, guidance documents, Health Authority inspection reports — ensuring risks are reviewed, escalated, and actioned appropriately * Design and deliver impactful training programs that sharpen team expertise and maintain audit and inspection readiness * Support GVP Inspections in close collaboration with the PV Quality function # What You Bring Education and Experience * University degree in health or life sciences, or a nursing qualification (preferred) * 10+ years in the pharmaceutical industry, with at least 5 years in Pharmacovigilance or a related discipline (Regulatory Affairs, Clinical, Medical Information) * Minimum 3 years of hands-on experience in GVP Deviation and/or Inspection Management * Proven track record leading quality management, compliance, or audit functions within pharma * Demonstrated success managing cross-functional teams and delivering complex strategic projects Skills and Capabilities * Expert-level proficiency in deviation investigation and CAPA development, including root cause analysis methodologies (Five Whys, Is/Is Not, cause-and-effect analysis) * Exceptional communication skills — able to distil complex compliance data into clear, compelling narratives for senior stakeholders * Strong influencing and negotiation abilities,...