Director, R&D Quality Risk Management

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.

The Research & Development Quality Risk Management Director will be responsible for the Quality Risk Management strategy in the Global R&D organization and will support QRM activities in the R&D functional units related to the QRM process.

This role works closely with the QRM Business Process Owner and will provide input to the QRM Community of Practice from a R&D perspective.

Responsibilities will include:

Provides regular reporting and results to cross functional management team

Providing strategy and development of tools for ensuring quality risk management and inspection readiness to R&D organization with regards to QRM requirements

Collaborate with and lead multidisciplinary or cross-functional QRM work/project teams; and serves as a strategic lead within the QRM working group

Owns the RDQ Quality Risk Register

Actively monitors and maintains industry-wide expertise of Quality Risk Management

Collaborate with key stakeholders to develop and implement a process for management of quality issues

Own issue identification and escalation processes.

Drive identification of root cause analysis, mitigation and CAPA implementation with a view to understand & address effectiveness

Initiate notification and/or escalation of emerging and significant risks to the relevant senior management and governance bodies, as appropriate

Support process improvement activities within QRM Oversight to drive key deliverables as required and ensure timely completion of activities

Basic Qualifications
  • Bachelors degree or equivalent years of additional experience
  • 8+ years of experience in a GxP regulated discipline

Preferred Qualifications
  • Knowledge of the global drug development process
  • Experience in a GxP quality role is required and experience in clinical operations
  • Experience in and/or knowledge of risk management in a regulated industry
  • Ability to operate in a matrix organization
  • Up to 25% domestic and international travel
  • Degree in a life science, natural science or business

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.