Senior Manager, PV Process Quality Lead

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.

Responsibilities

• 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, with sound judgment on escalation and conflict resolution
• Highly organized with the ability to manage multiple high-priority workstreams under stringent timelines, including inspection readiness activities
• Proficient in pharmacovigilance tools, corporate QMS platforms, document management systems (SharePoint), and Microsoft Office Suite
• Deep knowledge of global pharmacovigilance regulations and the ability to serve as an internal subject matter authority
• Proactive mindset for identifying process improvement opportunities and driving efficiency across the Patient Safety organization
• Additional Information
• Travel: Approximately 10-25%, including overnight travel
• #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

Benefits

Additional Information

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 .

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