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Associate Director GxP External Engagement

Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: May 16, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • In collaboration with Lead, GXP External Engagement, support the routine compliance surveillance activities to detect, monitor, collate and communicate global compliance trends which could impact GPS operations
  • Identify and engage with existing compliance surveillance activities across company to ensure robustness and effectiveness of the program.
  • Identify, interpret, assess, and communicate emerging surveillance of regulatory and compliance landscape
  • Collect, and analyze data from multiple internal sources and identify patterns, insights and trends and ensure appropriate actions are taken, as appropriate to mitigate.
  • Support data-driven insights into compliance performance and opportunities for improvement
  • Advance compliance expertise at company by providing education, knowledge sharing and other modes of learning--
  • Oversee compliance surveillance databases, ensure functionality and utility of archival systems--
  • Supporting the Lead, GxP External Engagement, effectively communicate the outcomes of external engagement across the organization, and ensure a closed loop mechanism to drive company action and impact where needed
  • Timely identify and assess emerging topics/expectations to define the company--s strategy and involvement
  • Benchmark best practices in the industry to continuously improve internal processes and systems for development and manufacturing
  • Actively participate in association meetings to develop relationships and build intelligence on upcoming regulatory changes and emerging compliance expectations that impact Quality, Compliance & Operations functions--
  • Extensive experience within regulatory agencies or the Bio/Pharmaceutical Industry, including leadership experience in Quality, Manufacturing, Regulatory and/or Product Development.
  • Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies--
  • Understanding of technical areas related to pharmaceutical and/or biological manufacturing, regulatory and quality control/quality assurance processes
  • Comprehensive understanding of one of more GxP areas and have willingness to expand knowledge into other areas.--
  • Experience in global or regional clinical operations or biologic products is preferred
  • Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
  • Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulatory/industry boundaries to find common solutions and drive positive impact and benefits for patients
  • Ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)
  • Pragmatic approach with demonstrated ability to make sound, risk-based decisions
  • Excellent oral and written communication skills.
  • Ability to be flexible and adapt quickly to the changing needs of the organization
  • Demonstrated high degree of independence with effective presentation and interpersonal skills to ensure a team-oriented approach

Keywords: Bristol-Myers Squibb, New Brunswick , Associate Director GxP External Engagement, Executive , New Brunswick, New Jersey

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