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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.


Responsibilities:

  • 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


Requirements:

  • 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 careers@corcept.com

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