Clinical Quality Manager

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Location
Richmond, VA
Salary
$110,000 - $130,000
Job Type
Direct Hire
Degree
Bachelor
Date
Jan 03, 2019
Job ID
2648431
Clinical Quality Manager

This Fortune 200 Company is searching for a Clinical Quality Manager to join their Regulatory Affairs team. In this role, you will be responsible for creating and enhancing clinical quality requirements and standards for their network of Contract Research Organizations (CROs) and will work with multiple business partners to prepare and assure FDA inspection readiness. In addition, this role will conduct quality system gap assessments to evaluate clinical operations quality systems for conformance to requirements and then assist in the development and tracking of gap remediation plans.

Clinical Quality Manager - Accountabilities include:
  • Leading Clinical Quality Management Reviews (summarizing quality audits, deviations and CAPA trends for leadership and the Clinical Operations group). Presenting clinical quality updates at CRO and bioanalytical lab governance review meetings.
  • Evaluating and reviewing clinical trial deviation trends to ensure appropriate investigations are conducted.
  • Leading, developing, and managing CRO Quality Agreement responsibilities.
  • Developing audit schedules and conducting/coordinating supplier GCP/GLP audits including, CRO, clinical site, and bioanalytical audits. Reviewing supplier data integrity program.
  • Participating in quality management system (GLP, GCP) audits to oversee supplier audit practices.
  • Leading preparation of GCP and GLP- related inspections by regulatory authorities, including participation in the preparation of responses to external regulatory inspections.
  • Leading and coordinating assessment of Clinical Operations.
  • Leading or participating in corrective actions and programs designed to enhance the quality and compliance of the organization.
  • Escalating internal and external situations which may pose quality/compliance risks.

Clinical Quality Manager - Qualifications include:
  • A Bachelor's degree in a physical science, engineering, or related field.
  • A minimum of 10 years of relevant experience in FDA regulated clinical quality systems and operations (pharmaceuticals, medical devices and/or dietary supplements).
  • Experience with providing FDA, ICH and other regulatory guidance to support clinical team’s preparation for agency inspections.
  • Detail orientation; strong analytical and organizational skills.
  • Ability to tactfully, independently and persuasively provide critical and sensitive feedback to the most senior levels of management.
  • The ability to travel up to 30% throughout the year (domestic and international).