Quality Assurance Manager
Basking Ridge, NJ 07920
This position performs and manages an auditing schedule that encompasses all phases of clinical development and assures that all studies performed are compliant with GCP requirements. Duties of this role include supporting all aspects of GCP regulatory inspections internally at facilities as well as externally at service providers and investigator sites. This level also provides training to study teams on GCP requirements. Additionally, this position interacts with Quality Assurance functional and cross-functional teams and has contact with external auditees, e.G., vendors and study sites, and communicates with QA consultants. This position consults on procedural and study related issues and escalates issues of elevated risk to Senior Management. This position makes the majority of decisions based on the interpretation of established guidelines, regulations, and procedural documents which requires problem solving skills.