Director, R&D Quality Intelligence

Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Strategy

• Develop strategy and structure regulatory intelligence tailored for R&D Quality
• Identify new or revised legislation/regulation/guidance relating to Good Clinical Practice, Product Development Quality, Pharmacovigilance and Good Laboratory Practice
• Performs impact assessment and proposes key initiatives to meet organization needs
  

Monitor Trends

• Monitors global health authorities and industry trends
• Evaluates audit/inspection reports from various sources (internal/external)
  

Internal & External Engagement

• Engages in and drive activities in internal Forum to ensure alignment in interpretation and dissemination of applicable regulations, guidelines and BMS policies and procedures to peers and stakeholder
• Identifies speaker/chair opportunities for RDQ at training/conferences/seminars
• Represents RDQ and coordinates RDQ involvement with quality associations, consortiums or Trade Associations
• Interfaces with functional groups in RDQ and GQ to build knowledge of GxP regulations and routinely engage in influencing the external environment through appropriate QA actions
  

Communication

• Provides quarterly updates at townhalls and Quality Councils
• Updates the internal communication feeds with appropriate content that enhance the visibility of RDQ and proliferate quality information throughout BMS
• Shares Quality Intelligence, both within RDQ and GQ and execute knowledge sessions
  

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.