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Senior Manager, Quality Management Systems

Job Description:

The Senior Manager, Quality Management Systems is responsible for developing and maintaining Corcept's internal GxP quality systems and their interface with external GxP systems.


Responsibilities:

  • Lead the Corcept effort for continuous improvement of the Quality Management System (QMS).
  • Manage the maintenance of SOPs, training programs, deviation and corrective action reports, commercial and investigational product complaints, vendor qualification and auditing program, and the documentation of these activities.
  • Organize and train personnel regarding regulatory agency inspection readiness and assist during inspections.
  • Develop and maintain systems for efficiently and securely storing GxP training materials, records and documents supporting Corcept's commercial and development activities.
  • Assist in quality management Pharmacovigilance and Clinical QA activities including the scheduling of GPVP and GXP internal and vendor audits and resolution of findings.


Requirements:

  • 10+ years' experience in the development and maintenance of quality systems in commercial-stage pharmaceutical companies.
  • Recent experience or any experience in a virtual company that is largely paper-based.
  • FDA Inspection experience for a) creating, revising and setting up logistics training and keeping personnel refreshed on training b) organizing mock inspections c) interacting with FDA Investigators when they visit & other activities they've fulfilled during an inspection.
  • Experience in working with all GxP departments including a Clinical Operations team (level of knowledge of clinical study projects).


Preferred Skills, Qualifications, or Technical Proficiencies:

  • Ability to prepare for and defend regulatory agency inspections.
  • Experience in developing GxP SOPs and training personnel regarding those SOPs and the government regulations to which they respond.
  • Thorough understanding of quality systems that support internal GxP activities for pre-clinical, clinical and commercial products.
  • Training Presentation skills on GxP-related subjects for personnel. (also organizing/booking trainings for personnel such as webinars, on-site GxP speakers, etc.).
  • Internal and External auditing skills.


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

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