Senior Manager, Quality Management Systems - Menlo Park , CA | Biospace
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Senior Manager, Quality Management Systems

Corcept Therapeutics Inc.

Location:
Menlo Park , CA
Posted Date:
7/26/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Compliance, Quality Assurance, Regulatory,

Job Description

Develop and maintain Corcept’s internal GxP quality systems and their interface with external GxP systems.
•   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.
•   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.