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Vice President, Quality Assurance

Job Description:

The Vice President, Quality Assurance (QA) will lead the management and continued development of Corcept’s Quality Management System and ensure that Quality is central to the way Corcept does business.


  • Ensure compliance with domestic and international current good practice quality guidelines and regulations including Good Manufacturing, Clinical, Laboratory, Distribution and Pharmacovigilance Practices (collectively, “GxPs”)
  • Ensure that commercial and clinical drug product is manufactured, tested, released and distributed in accordance with Corcept’s established specifications, procedures, clinical requirements and appropriate GxP standards
  • Provide QA oversight of internal and external clinical and pharmacovigilance activities
  • Schedule and execute internal and external audits of GxP activities and vendors
  • Select, develop, manage, and evaluate QA personnel
  • Provide regular reports to Senior Management regarding the performance, effectiveness and strategies for continuous improvement of the QMS
  • Prepare for and manage regulatory agency inspections


  • At least fifteen years’ experience in pharmaceutical QA
  • Undergraduate or advanced degree in a scientific discipline
  • In depth knowledge of EU GxP and other applicable regulatory requirements; experience working with EU Qualified Persons
  • Experience with small molecule manufacturing and oral dosage forms
  • Good verbal, written, and interpersonal communication skills

Preferred Skills, Qualifications, or Technical Proficiencies:

  • Expert knowledge of relevant scientific principles and concepts

If you are interested, please submit your resume by email to

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