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VP of Corporate Quality

Company: Pharmaceuticals, Raleigh, NC
Location: Raleigh
Posted on: September 15, 2018

Job Description:

Description

As a Vice President of Corporate Quality you will be responsible for the strategic direction, management oversight and resourcing, of Quality Assurance globally, including Quality Assurance for the Americas, Europe, Middle East and Africa, and Asia Pacific.

Essential Functions: Directs and provides oversight of a comprehensive, global Quality Assurance program that contributes to the Company’s Quality Management System, including the conduct of independent audits internally and externally and the hosting and support of sponsor audits and regulatory inspections. Oversees the development and maintenance of the annual Audit Plan that assures assessments of an adequate risk-based sample of the processes, systems, vendors and projects to enable a reliable determination of the status of compliance across the Company’s operations. Ensures that adequate and well-trained resources are in place to meet the goals of Quality Assurance. Ensures that a robust set of Quality Assurance Standard Operating Procedures and Work Instructions are in place and continuously enhanced. Ensures that adequate tools and systems are in place and regularly enhanced to effectively and efficiently manage Quality Assurance activities. Provides audit and inspection-related metrics and other key Quality Assurance related updates to executive leadership with the ultimate goal of process improvement. Provides quality-related advice and counseling in particularly complex areas both internally and during sponsor meetings. Serves as a Corporate Quality leadership representative in bid defenses and executive steering committee meetings with sponsors, as appropriate. Participates in key external meetings to ensure that Company is consistently at the forefront of the industry and to influence the strategic direction of Quality Assurance. Other Responsibilities:

Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications

Advanced degree preferred plus extensive experience (minimum of 15 years) in Quality Assurance management roles globally in a clinical research environment, or an equivalent combination of educational and professional experience. Prior experience in a Contract Research Organization is a plus. Requires extensive and comprehensive knowledge of regulations and guidelines pertaining to Good Clinical Practice. Knowledge of regulations and guidelines pertaining to Pharmacovigilance is a plus. Ability to handle multiple tasks in a dynamic environment, and to effectively communicate with, motivate and influence staff at all levels of the organization is essential. Requires effective organizational, presentation, documentation, facilitation and interpersonal skills.

Keywords: Pharmaceuticals, Raleigh, NC, Raleigh , VP of Corporate Quality, Executive , Raleigh, North Carolina

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