Director, Clinical Quality Assurance

The Director of Clinical Quality Assurance (CQA) will lead and perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored or supported by Corcept. This is a hybrid role typically requiring on-site presence at least 3 days per week.

Requirements

• Lead Clinical Quality Assurance activities
• Champion and influence management and growth of the Clinical Quality Assurance team
• Lead, manage, and train others on GCP audits
• Serve as a QA representative on clinical product and study development teams
• Drive the review and approval of clinical study documents and clinical SOPs / Guidance Documents
• Manage study and program specific Clinical Study Audit Plans (CSAP) compliance
• Lead and drive continuous improvement of the Corcept Quality Management System (CQMS)
• Work with CQA leads to set inspection readiness strategy for therapeutic areas
• Play key role in managing clinical inspections conducted by regulatory agencies
• Conduct and/or manage qualification audits of GCP service providers
• Use risk-based approach to implement clinical program audit plans
• Lead or support sponsor or contract research organization (CRO) inspections conducted by regulatory agencies
• Lead quality metric analyses for CQA including study quality event trends from clinical process deviations / CAPAs
• Maintain knowledge of agency and industry trends, standards, and methodologies related to GCPs
• Provide cross training development opportunities, mentor and coach junior QA team members

Benefits

• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Generous Paid Time Off