Full-Time

Manager – Clinical Quality Assurance

Confirmed live in the last 24 hours

Corcept Therapeutics

Corcept Therapeutics

201-500 employees

Develops cortisol modulation therapies for diseases

Biotechnology

Compensation Overview

$144.8k - $170.3kAnnually

Senior

Menlo Park, CA, USA

Required Skills
Quality Assurance (QA)
Google Cloud Platform
Requirements
  • Understanding of Quality Systems that support GCP quality activities
  • Experience developing GCP processes for the best industry practices and training
  • Strong proficiency in Microsoft Office
  • BS / BA (science or related field) or equivalent experience
  • 6 or more years clinical research experience
Responsibilities
  • Lead/manage Good Clinical Practice (GCP) audits
  • Serve as a QA representative and support clinical study teams
  • Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents
  • Manage study-specific Study Audit Plans compliance
  • Review and approve investigational product (IP) temperature excursions
  • Lead continuous improvement of the Clinical Quality Management Systems (CQMS)
  • Manage and support inspection readiness activities for GCP
  • Support clinical inspections conducted by regulatory agencies
  • Lead clinical non-compliance event investigations and CAPA implementation
  • Perform quality metric analysis for CQA
  • Maintain a contemporary knowledge of agency and industry trends
  • Provide cross-training development opportunities to QA team members

At Corcept Therapeutics, we specialize in pioneering selective glucocorticoid receptor antagonists. Our focused efforts extend to over 30 active studies aimed at addressing the detrimental impacts of excess cortisol in endocrine, metabolic, oncologic, and psychiatric conditions. We are dedicated not only to advancing medical science but also to prioritizing the well-being of our team, ensuring a collaborative and supportive work environment that fosters innovation and professional growth.

Company Stage

IPO

Total Funding

$119.1M

Headquarters

Menlo Park, California

Founded

1998

Growth & Insights
Headcount

6 month growth

12%

1 year growth

22%

2 year growth

46%