QA Manager II, Compliance/Training (NCI) - (Frederick, MD)

Description: PROGRAM DESCRIPTION The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases. KEY ROLES/RESPONSIBILITIES Compliance Manager The Compliance Manager is responsible for: Managing the overall quality system program consisting of at least 5 (5) staff Managing internal and external supplier audits to ensure that vendors meet quality requirements Managing and ensuring compliance with internal (quality system audit methodology) and external (regulatory) requirements Determining audit scope to ensure that it is targeted and specific Developing annual audit schedules concentrated on key business processes per a risk based approach, managing corrective action plans, following up on agreed upon CAPAs, and tracking the closure of audit findings