Bristol-Myers Squibb Company

Director, Clinical Training, Process & Continuous Improvement

Location
Princeton, NJ, US
Posted
May 12, 2018
Ref
R1503440
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

The role Director, Clinical Training, Process & Continuous Improvement will be placed within the Global Clinical Compliance & Continuous Improvement function of Global Clinical Operations (GCO). This role will support and enable corporate GCO compliance objectives through support of the development of the GCO technical training profiles and requirements, based on the activities identified through the BMS Quality Management System (QMS), audit and inspection outcomes to assure the processes are built/adapted as needed in support of quality by design principles. The role will be responsible for the development and implementation of the annual GCO Quality Management Plan (QMP).

This role will lead a team of GCO employees who have demonstrated and core expertise in Good Clinical Practice (GCP), ICH and Health Authority expertise who are focused on identification of process issues, development & implementation of the annual GCO Quality Management Plan, technical training profiles for all roles within GCO.

Principal Responsibilities:
  • Collaborate with key stakeholders to develop and implement a process for management of quality issues
  • Initiate notification and/or escalation of emerging and significant risks to the relevant senior management and governance bodies, as appropriate
  • Drive the development of new and modification of the core GCO processes in support of clinical trial execution in accordance with key objectives and needs of the department
  • Drive the development of the training curriculum for new hires to GCO and for the ongoing technical training needs across the multiple roles within GCO
  • Leverage the BMS audit tracking system for the generation of periodic and ad hoc status reports on quality issues and events for trending and report out in BMS Quality System Management Reviews which lead to process enhancements and training activities to assure a quality mindset
  • Support process improvement activities within QMS Oversight to drive key deliverables as required and ensure timely completion of activities


Qualifications:
  • A minimum of a Bachelor's Degree (or equivalent degree) is required. Degree in a life science, natural science or business is preferred.
  • At least 8 years of experience in a GxP regulated discipline is required.
  • Knowledge of the global drug development process is required.
  • Experience in a GxP quality role is required and experience in clinical operations is preferred.
  • Experience in and/or knowledge of risk management in a regulated industry is required.
  • Ability to operate in a matrix organization is preferred
  • Up to 25% domestic and international travel may be required.