Posted to MedZilla on 10/6/2017


Barrington James

US-Central, Quality Assurance Manager JDQA1-MZ


 
 

(1) MANAGER OF QUALITY ASSURANCE

POSITION DESCRIPTION:
The Manager of Quality Assurance is responsible for providing leadership and implementing and driving the quality management process for the organization. Specifically this position will ensure the quality and compliance of sponsored clinical trials and other clinical activities. Additionally this position will ensure the quality and compliance of contract manufacturers primarily through Good Manufacturing Pracitices (GMP). The successful candidate will be able to: prepare, schedule, coordinate, and conduct audits in accordance with established QA goals and objectives; communicate with internal departments of upcoming audits and schedule the audits in cooperation with personnel from Clinical Operations and other relevant internal departments/functions, as well as external vendors and investigator sites; effectively conduct the audits, draft Audit Reports, and submit these Reports to management for review and input; assist in inspection readiness activities; attend Clinical Trial team meetings; remain current with new/revised global regulations/guidelines; prepare and maintain all quality related documentation including standard operating procedures (SOPs) in support of the quality compliance; and develop and conduct appropriate quality training.

KEY RESPONSIBILITIES:

  • Establish & maintain quality systems, including but not limited to change control; vendor qualification; internal and external audits; SOPs; and process improvement
  • Responsible for quality oversight of Contract Research Organizations (CROs) and Contract Manufacturers (CMOs) and global supply chain
  • Provide GMP, GLP and GCP training as needed
  • Create and review quality agreements
  • Review and approve master production records, validation protocols and specifications
  • Prepare, review and issue quality investigation and CAPA reports, and periodic quality trend reports
  • Provide input on all quality related matters
  • Ensure internal inspection readiness at vendors
  • Provide IND and NDA support, as required, including preparation of regulatory filings

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