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Clinical QA Manager

Trenton Metro Area, NJ

Post Date: 03/12/2018 Job ID: JN -032018-21111 Job Type: Clinical
  • 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.

    Essential Functions:

  • 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.

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