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Associate Director, Clinical Quality Assurance

Job Description:

The Associate Director, Clinical Quality Assurance will provide quality oversight for GCP compliance of Corcept clinical operations and contract service providers.


Responsibilities:

  • Lead the Corcept effort for continuous improvement of the Clinical Quality Management System (CQMS), including creation and revision of SOPs and training programs for GCP compliance
  • Serve as QA representative on clinical product and study development teams; participate in the review and approval of required clinical documentation, including protocols and protocol amendments
  • Conduct and/or manage qualification inspections of GCP service providers and routine and for-cause audits of clinical investigator sites, including review of TMFs and CSRs
  • Create and execute clinical study audit plans
  • Participate in department cross-training and provide general assistance during regulatory inspections, serving as QA expert and backup escort during inspections
  • Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs
  • Travel required


Requirements:

  • BA/BS degree in biological sciences, pharmacy or related field and 10+ years' experience in the development and maintenance of clinical quality systems and performing GCP audits for clinical stage pharmaceutical companies


Preferred Skills, Qualifications, or Technical Proficiencies:

  • Ability to prepare for and defend regulatory agency inspections
  • Experience in developing GCP SOPs and training personnel regarding those SOPs and the government regulations to which they respond
  • Thorough understanding of quality systems that support internal GCP activities for clinical documentation and products


If you are interested, please submit your resume by email to hr@corcept.com

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