Quality and Infrastructure Manager

Bristol-Myers Squibb Princeton, NJ

About the Job

Description:

This position supports the Central Clinical Planning and Solutions (CCPS) organization and reports to the Head of Clinical Partner Management.  As an integral member of the CCPS, the Quality and Infrastructure Manager drives quality management processes with operational teams, support functions and service providers

The Quality and Infrastructure Manager will be asked to efficiently and independently perform the responsibilities for this role as outlined below\:

  • Implementation of the risk-based vendor quality oversight framework
  • Provide operational expertise and collaborate with the quality organization and external partners to drive effective end to end quality management of service providers
  • Enhance tools and processes for quality and infrastructure with service providers
  • Ensure compliance with legal / human resource / regulatory standards, ethical practices, BMS outsourcing and procurement policies and procedures.
  • Align teams to the related BMS outsourcing strategies by enabling them with relevant information and guidance on quality processes
  • Communicate effectively and train stakeholders (clinical teams, R&D Quality, BMS Vendor and outsourcing management, service providers)
  • Liaise with R&D Quality to develop clinical vendor audit strategy to monitor key vendors based on risk
  • Manage vendor assessment process compliance, via the use of a fit for purpose approach and development of relevant tools
  • Coordinate Vendor Assessment (VA) activities for GCO and as applicable other business units
  • Develop, implement and track Key Performance Indicators on Vendor Assessments.

Qualification:

Requirements

  • Degree in Life science, Business Administration or equivalent.  Advanced degree a plus
  • Clinical development experience of 5 years required, with Scientific, Quality, Audit and/or Project management experience desired
  • Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate
  • Effective project management of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure and to manage multiple activities simultaneously
  • Ability to sustain high levels of performance in a constantly changing environment
  • Understanding of the clinical development process / global regulations (eg. GCPs, 21CFR Part II), local regulations as they apply to scope of outsourcing
  • Excellent oral and written communication skills and diplomacy to convey information and influence others with a strong customer focus
  • Strong computer skills including MS Office, experience working with SharePoint site architecture and management