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Vendor Oversight Framework Lead

Bristol Myers Squibb Company

This is a Contract position in Hopewell, NJ posted March 24, 2020.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.

We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment.

We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

In close collaboration with the Vendor Oversight Process Lead Lead the implementation a standardized integrated framework of GxP service provider oversight,allowing necessary flexibility to adjust for specific provider and study risk mitigation needs.

Ensure the delivery the enterprise and trial level defined processes, tools, templates and record keeping standards that will support oversight of GxP service providers.

Provide business owner input into the Information Technology (IT) solution(s) contributing to the framework of oversight.

Collaborate with CTBP and BMS functional subject matter experts to drive the evolution of oversight of GxP service providers with active studies to a framework harmonized and aligned to the standardized framework.

Build and maintain relationships with key stakeholders to ensure continuous business process alignment, IT solutions, and timely adoption of changing regulations and/or Standard Operating Procedures (SOPs) changes.

Contribute expertise and support for internal and external governance meetings and quality councils.

Support communication and change management through all levels of the organization to ensure adherence to the oversight model and efficient execution of activities.

Identify and implement innovative but regulatory compliant approaches to oversight framework.

Ensure continuous business process (SOPs, tools, templates, IT) improvements and timely adoption to position BMS to be efficient and compliant with regulatory requirements.

Evaluate, review and recommend metrics to ensure proper oversight of suppliers across various functions.

Aid in Quality and Corrective and Preventative Action (CAPA) management Desired Experience Bachelor’s degree required; advanced academic degree preferred Minimum 10 years of experience in directly overseeing GxP service providers performance and quality.

The preferred candidate will also have at least 5 years of Project Management, including operationalizing clinical trials experience.

Experience supporting or leading organizational change management.

Experience leading teams through process improvement initiatives.

6 Sigma or similar methodology trained preferred / a risk-based quality by design mindset.

Demonstrated ability translate a strategy into actionable plans and manage implementation.

Demonstrated effective communication to a diverse audience at multiple levels within the company.

Escalates and keeps leadership aware of status, issues Track record of leading through influence, working across complex, global organizational matrices Demonstrated ability of managing and working with cross-functional / teams in a complex, changing environment to deliver value-added results to the organization Balances priorities and multiple demands in a responsive and professional manner 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.