Senior Manager, PV Process Quality Lead

Working with UsChallenging. 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 RoleAt 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 DoLead the strategic investigation and closure of high-impact GVP deviations, shaping remediation priorities and organizational risk management at a senior levelDrive enterprise-wide CAPA management and quality risk initiatives, ensuring full alignment with global regulatory requirementsDeliver advanced root cause analyses and trend intelligence, translating complex data into persuasive recommendations for senior leadershipMaintain and evolve QMS documentation, setting policy standards for deviation management, management notification, and CAPA processesBuild and champion cross-functional partnerships across R&D and BMS, embedding a consistent culture of quality and continuous improvementServe as the internal authority for global Deviations and CAPA networks, influencing enterprise IT systems and processes to meet GVP requirementsLead the Pharmacovigilance Safety Quality Forum, reporting quality events, audit CAPAs, and risk management findings to senior Patient Safety leadershipOversee 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 appropriatelyDesign and deliver impactful training programs that sharpen team expertise and maintain audit and inspection readinessSupport GVP Inspections in close collaboration with the PV Quality functionWhat You BringEducation and ExperienceUniversity 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 ManagementProven track record leading quality management, compliance, or audit functions within pharmaDemonstrated success managing cross-functional teams and delivering complex strategic projectsSkills and CapabilitiesExpert-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 stakeholdersStrong influencing and negotiation abilities, with sound judgment on escalation and conflict resolutionHighly organized with the ability to manage multiple high-priority workstreams under stringent timelines, including inspection readiness activitiesProficient in pharmacovigilance tools, corporate QMS platforms, document management systems (SharePoint), and Microsoft Office SuiteDeep knowledge of global pharmacovigilance regulations and the ability to serve as an internal subject matter authorityProactive mindset for identifying process improvement opportunities and driving efficiency across the Patient Safety organizationAdditional InformationTravel: Approximately 10–25%, including overnight travel#LI-HybridIf 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 CareersWith 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 ProtocolBMS 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-