Director, Clinical Quality Assurance

The Director of Clinical Quality Assurance (CQA) is a senior member of the CQA team and 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 3 days per week.

Responsibilities:

• Lead Clinical Quality Assurance activities as line manager to assigned CQA Leads and working with therapeutic area teams to support success of the clinical studies sponsored or supported by Corcept
• Champion and influence management and growth of the Clinical Quality Assurance team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team’s capabilities meet Corcept’s future needs
• Lead, manage, and train others on GCP audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs)
• Serve as a QA representative and support clinical study teams and therapeutic area teams to provide compliance advice and strategy
• Serve as a QA representative on clinical product and study development teams, and to provide strategic and compliance advice; participate in the review and approval of required clinical documents
• Drive the review and approval of clinical study documents and clinical SOPs / Guidance Documents as required
• Manage study and program specific Clinical Study Audit Plans (CSAP) compliance for assigned program by using risk-based approach for Corcept clinical studies
• Lead and drive continuous improvement of the Corcept Quality Management System (CQMS), including creation and revision of SOPs and training programs for GCP compliance and excellence
• Work with CQA leads to set inspection readiness strategy for therapeutic areas and manage and support inspection readiness/preparation activities for GCP
• Play key role in managing clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigator site inspections, and contract research organization (CRO) inspections. Support GMP, GLP, and PV inspections as needed
• Conduct and/or manage qualification audits of GCP service providers, clinical investigator sites, clinical department internal audits, and applicable study document audits, including review of TMFs and CSRs
• Use risk-based approach to implement clinical program audit plans, and clinical program inspection readiness effort with clinical teams. Lead or support sponsor or contract research organization (CRO) inspections conducted by regulatory agencies
• Lead and support clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checks
• Lead quality metric analyses for CQA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data
• Maintain knowledge of agency and industry trends, standards, and methodologies related to GCPs. Lead the GCP regulatory surveillance program
• Provide cross training development opportunities, mentor and coach junior QA team members
• Travel required

Preferred Skills, Qualifications and Technical Proficiencies:

• Ability to prepare for and defend regulatory agency inspections
• Ability to perform GCP audits is required
• Experience in developing GCP SOPs and training personnel regarding those SOPs and the government regulations to which they respond
• Thorough understanding of the quality systems that support internal GCP activities for clinical documentation and commercial products
• Advanced Microsoft application skills (Word, Excel, PowerPoint)
• Experience in developing GCP processes for the best industry practices and training personnel

Preferred Education and Experience:

• BA/BS degree in biological sciences, pharmacy, related field, or equivalent experience is required
• 12+ years’ experience development and maintenance of clinical quality systems and performing GCP audits for clinical stage pharmaceutical companies is preferred

The pay range that the Company reasonably expects to pay for this headquarters-based position is $218,200 - $256,700; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.