Hybrid Associate Director, Clinical QA

Corcept Therapeutics; Redwood City (CA); Hybrid; USD 193,000 - 227,000; Full time

Job summary

Corcept Therapeutics in Redwood City, CA is seeking an Associate Director of Clinical Quality Assurance to lead day-to-day CQA operations across clinical programs and ensure regulatory compliance for Corcept's studies.

This hybrid role requires on-site presence three days per week and a track record of building and mentoring high-performing QA teams, developing risk-based audit plans, and coordinating inspections.

Qualifications

• 10+ years in development and maintenance of clinical quality systems and performing GCP audits.
• Experience preparing for and defending regulatory inspections and audits.
• Proven ability to develop GCP SOPs and train personnel on regulatory requirements.
• Strong understanding of quality systems supporting GCP activities and documentation.

Responsibilities

• Lead Clinical Quality Assurance activities and oversee CQA team members for multiple studies.
• Develop and manage study audit plans using a risk-based approach.
• Lead GCP audits including investigator sites, TMF, and CSRs.
• Support internal process audits and CtQ risk management for studies.
• Represent CQA on assigned studies and oversee CQMS improvements.
• Coordinate regulatory inspections and support, including sponsor and site inspections.
• Mentor junior QA staff and ensure training and competency.
• Travel required.

Skills

Regulatory inspections

GCP audits

SOP development

Quality systems

Microsoft Office

Education

BA/BS in biological sciences or related field

Job description

Corcept Therapeutics in Redwood City, CA is seeking an Associate Director of Clinical Quality Assurance to lead day-to-day CQA operations across clinical programs and ensure regulatory compliance for Corcept's studies.

This hybrid role requires on-site presence three days per week and a track record of building and mentoring high-performing QA teams, developing risk-based audit plans, and coordinating inspections.