Associate Director, Clinical Quality Assurance

The role

The Associate Director of Clinical Quality Assurance leads and performs day-to-day CQA operations and compliance activities at the clinical program level. This person supports the success of clinical studies sponsored by Corcept.

What you will do

• Lead Clinical Quality Assurance activities and oversee assigned CQA team members
• Support the management and growth of the CQA team
• Develop and manage study audit plans using a risk-based approach
• Lead and manage Good Clinical Practice (GCP) audits
• Support clinical service provider and clinical development internal process audits
• Assess changes to qualified service provider services and their impact to ongoing clinical studies
• Serve as a CQA Lead representative on assigned clinical studies
• Evaluate new processes and initiatives impacting clinical programs/studies
• Support clinical study teams in risk management activities
• Review clinical study documents and plans and provide CQA compliance review and approval of clinical development SOPs

Required qualifications

• Ability to perform GCP audits
• Excellence in basic Microsoft Office applications (Word, Excel, PowerPoint)
• BA/BS degree in biological sciences, pharmacy, related field or equivalent experience

Nice to have

• Ability to prepare for and defend regulatory agency inspections
• Experience in developing GCP SOPs and training personnel regarding those SOPs and the government regulations to which they apply
• Thorough understanding of the quality systems that support internal GCP activities for clinical documentation and clinical trials
• 10+ years’ experience development and maintenance of clinical quality systems and performing GCP audits for clinical stage pharmaceutical companies

About the company

Corcept is focused on the science of cortisol to address diseases. The company is headquartered in Redwood City, California.