Clinical QA Manager
Trenton Metro Area, NJ
- Clinical Quality Assurance Manager is responsible for managing Quality Assurance systems, processes and conducting internal and external audits, training, and reporting according to internal standards and GxP regulations and guidelines.
Education and Experience
Bachelor s Degree in science/life sciences preferred with 7 to 10 years experience, 4 to 7 years with advanced degree e.g. MS, MBA, PharmD, PhD in drug development and a minimum of 4 years of experience in GCP/GMP operations/auditing including detailed knowledge of FDA and ICH regulations.
- Performs and reports assigned GCP/GxP audits of clincal studies, including but not limited to clinical investigator sites, vendor/CROs, internal system/processes, and clinical data and documents.
- Provides input to the annual risk-based audit plan, schedule and execution of audits based on changing business environment and interaction with cross-functional teams.
- Prepares timely well-written reports, obtains/evaluates audit responses, and oversees tracking mechanism for QA audits and CAPAs as per internal standards.
- Provides ongoing feedback to management on potential quality related risks.
- Contributes to process improvement initiatives, develops/administers SOPs, as well as maintenance of other controlled documents in the quality document management systems.
- Maintains high degree of knowledge of global industry expectations, GCP/GxP regulations and provides expert advice/guidance to staff in support of GxP operations
- Supports Health Authority inspection activities for domestic and international projects.
- Provides/supports quality system/GxP training to staff as needed.
- Mentors and trains junior auditors, reviews and provides feedback to management
Position requires approximately 30% travel.