Associate Director, Clinical Quality Assurance
About The Position
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com. The Associate Director of Clinical Quality Assurance (CQA) is a lead member of the CQA team and will lead and perform day-to-day CQA operations and compliance activities at the clinical program level to support the success of the clinical studies sponsored by Corcept.
Requirements
- 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 apply
- Thorough understanding of the quality systems that support internal GCP activities for clinical documentation and clinical trials
- Excellence in basic Microsoft Office applications (Word, Excel, PowerPoint) is required
- BA/BS degree in biological sciences, pharmacy, related field or equivalent experience is required
- 10+ years’ experience development and maintenance of clinical quality systems and performing GCP audits for clinical stage pharmaceutical companies
- Applicants must be currently authorized to work in the United States on a full-time basis.
Responsibilities
- Lead Clinical Quality Assurance activities and oversee assigned CQA team members to ensure compliance oversight of all clinical studies within a clinical development program
- Support the management and growth of the CQA team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team’s capabilities meet Corcept’s current and future needs
- Develop/manage study audit plans ensuring compliance oversight for assigned studies by using a risk-based approach
- Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site, Trial Master File (TMF), and applicable study documents, including Clinical Study Reports (CSRs)
- 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 and provide compliance support and oversight throughout the study lifecycle
- Evaluate new processes and initiatives impacting clinical programs/studies as CQA representative and support the implementation as needed
- Support clinical study teams in risk management activities including the identification of critical to quality (CtQ) factors for each clinical study, implementing risk proportionate study activities in accordance with CtQs and the monitoring of identified risks to the CtQs
- Review clinical study documents and plans and provide CQA compliance review and approval of clinical development SOPs
- Manage and support GCP inspection readiness activities for assigned clinical program/studies in alignment with study milestones
- Support regulatory inspections in a key role for assigned programs, including sponsor, clinical investigator site, and service provider inspections
- Lead critical investigations, to ensure regulatory reporting compliance
- Support, review and approve clinical non-compliance records (deviations and CAPA)
- Lead continuous improvement of the Clinical Quality Management System (CQMS), including creation and revision of SOPs and training programs for GCP compliance and excellence
- Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies related to GCPs
- Provide cross training development opportunities; mentor and coach junior QA team members
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What This Job Offers
Job Type
Full-time
Career Level
Manager
