Bristol-Myers Squibb Company

Director, Regional Clinical Compliance

Location
Princeton, NJ, US
Posted
Apr 12, 2018
Ref
R1503441
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, Regional Clinical Compliance will be placed within the Global Clinical Compliance & Continuous Improvement function of Global Clinical Operations (GCO). This role will support and enable corporate GCO objectives through support of implementation of the GCO audit management plan, preparing and providing local on site local health authority inspection support assuring GCO is inspection ready at all times. This role will also assure the development and implementation of the global CRA accompanied program for GCO within both BMS and vendor based field CRAs.

The role will interact with the global quality function in support of any sponsor inspections and activities in any of the local markets. There will be a significant partnership with the Global Quality organization.

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 in support of the regional business activities primarily site relations, field CRAs and health authority interactions as needed.

Principal Responsibilities
  • Collaborate with key stakeholders to develop and implement a process for management of quality issues
  • Engage stakeholders to utilize processes and technologies in support of QMS processes
  • Embed a sustainable GCO Quality Culture & execute the GCO related QMS
  • Initiate notification and/or escalation of emerging and significant risks to the relevant senior management and governance bodies, as appropriate
  • Development of the GCO Accompanied Monitoring Program & implementation of such within the respective region
  • Identify trends from this program to enhance training and process improvements, assurance that findings from the Accompanied Monitoring Program are tracked and acted upon as part of a wider QMS
  • Oversee vendor activities in relation to monitoring activities in accordance with the Accompanied Monitoring Program
  • Support process improvement activities within QMS Oversight to drive key deliverables as required and ensure timely completion of activities
  • Identify and support the development & implementation of technical training across GCO and within the respective region
  • Assure inspection readiness within the respective region through implementation of the GCO audit management plan, on site support during site Health Authority inspections and/or local sponsor Health Authority inspections in partnership with BMS global quality organization
  • Coordinate local health authority site inspections or sponsor inspections as necessary

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 50% domestic and international travel may be required.