01Overview
Senior Manager, PV Quality Risk Management & Deviations Working with Us Challenging. Meaningful. Life-changing. Those arent 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. Youll 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 . Duties/Responsibilities Oversees, leads and directs strategic assessment, investigation, and closure of high-impact GVP deviations, influencing remediation priorities and organizational risk management decisions at a senior leadership level. Drives strategic projects and oversees process enhancements related to Deviations, Audit CAPA Management, and GVP Quality Risk Management, ensuring full alignment with global regulatory requirements and BMS quality standards. Develops and leads advanced trending and root cause analysis (including Fishbone, Five Whys, Is/Is Not methodologies), providing critical intelligence and persuasive recommendations to senior leadership for proactive compliance and quality improvements. Manages the GVP Risk Register; leads annual risk assessments and drives enterprise-wide QRM activities, including systematic identification, assessment, control, communication, and periodic review of pharmacovigilance quality risks. Collaborates with pharmacovigilance product medical leads, global process owners, subject matter experts, and third-party contract/process owners to ensure cross-functional coordination of risk assessments throughout the full product lifecycle, from first-in-human to global market withdrawal. During identification of potential third parties and external partners (vendors, distributors, business partners, development partners), assists with technical assessment as part of due diligence to determine quality, compliance capabilities, and health of the Quality Management System. undefined Maintains and refines QMS documentation, influencing policy standards for deviation management, management notification, CAPA processes, and QRM to ensure global regulatory compliance. Champions cross-functional partnerships with R&D, External Affairs, and BMS stakeholders, driving company-wide adoption of robust GVP deviation, CAPA, and QRM practices. Serves as Local Process Owner for GVP Quality Risk Management, providing vision and strategy; networks with all GxP Local Process Owners to create interdependencies and data sharing to identify quality risks across Patient Safety. Leads the reporting of Audit CAPA, GVP Quality Risk Management, and quality events/deviations at the Pharmacovigilance Safety Quality Forum ensuring senior PS leadership senior-level decision-making support and alignment. Develops and leads impactful training initiatives, elevating organizational expertise on deviation investigations, QRM, and CAPA, ensuring readiness for audits and health authority inspections. Ensures accuracy and strategic use of deviation, CAPA, and QRM data in the Pharmacovigilance System Master File (PSMF); proactively identifies and resolves complex issues with executive influence. Supports GVP Inspections (Health Authorities and Business Partners) in close collaboration with PV Quality and Compliance functions. If you come across a role that intrigues you but doesnt 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 .
