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
Benefits
Vision insurancePaid time off
Additional Information
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 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 at least 3 days per week.
Corcepttherapeutics · Redwood City, CA