Corcept Therapeutics

Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs). Support GMP, GLP, and PV inspections. Lead clinical non-compliance event investigations and CAPA implementation. Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies related to GCPs. Maintain the GCP regulatory surveillance program. Understanding of Quality Systems that support GCP quality activities

quality assurance

At Corcept Therapeutics, we believe the potential impact of cortisol modulation on the future of health has long gone overlooked. That is why for twenty-five years we have pushed the boundaries of what is possible, driven by fiercely independent science, open collaboration and the curiosity to follow the data wherever it leads. Our company is committed to building a culture that values diverse perspectives and the unique contributions of every employee. Our vibrant community is made up of over 300 people—medical practitioners, scientists, and industry professionals—all with the shared goal of advancing the science of cortisol modulation to treat serious disease. Our work has uncovered over 1000 proprietary selective cortisol modulators, including our marketed product, Korlym® (mifepristone), the first treatment available for those living with Cushing’s syndrome, a life-threatening condition caused by excess cortisol activity. Today, we have a unique opportunity to revolutionize the treatment of severe endocrine, oncology, metabolism and neurology disorders and aim to deliver better outcomes for the people affected by them. The Manager of Clinical Quality Assurance (CQA) is a key member of the CQA team and will perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored or supported by Corcept. Responsibilities: <ul><li>Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs)</li><li>Serve as a QA representative and support clinical study teams to provide compliance advice</li><li>Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents</li><li>Manage study-specific Study Audit Plans compliance for the assigned program by using a risk-based approach for Corcept clinical studies</li><li>Review and approve investigational product (IP) temperature excursions to ensure release or rejection of IP on time</li><li>Lead continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellence</li><li>Manage and support inspection readiness activities for GCP</li><li>Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigator site inspections, and contract research organization (CRO) inspections</li><li>Support GMP, GLP, and PV inspections</li><li>Lead clinical non-compliance event investigations and CAPA implementation</li><li>Perform quality metric analysis for CQA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data</li><li>Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies related to GCPs. Maintain the GCP regulatory surveillance program</li><li>Provide cross-training development opportunities to QA team members, and mentor/coach junior QA team members upon request or as an assigned supervisor</li><li>Some travel required </li></ul>Preferred Skills, Qualifications and Technical Proficiencies: <ul><li>Understanding of Quality Systems that support GCP quality activities</li><li>Experience developing GCP processes for the best industry practices and training</li><li>Strong proficiency in Microsoft Office </li></ul>Preferred Education and Experience: <ul><li>BS / BA (science or related field) or equivalent experience</li><li>6 or more years clinical research experience </li></ul>The pay range that the Company reasonably expects to pay for this position is $144,800 - $170,300; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered. Applicants must be currently authorized to work in the United States on a full-time basis. If you are based in California, we encourage you to read this important information for California residents linked here. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer

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