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Corcept Therapeutics · 1 hour ago

Manager, Clinical Quality Assurance

Redwood City, CA

Full-time

Hybrid

Mid, Senior Level

$154K/yr - $181K/yr

6+ years exp

Corcept Therapeutics is a leader in the research and development of cortisol modulators, dedicated to advancing treatments for serious diseases. The Manager of Clinical Quality Assurance will oversee clinical quality operations and compliance activities, ensuring the success of clinical studies through various audits and quality management processes.

BiotechnologyMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Lead/manage Good Clinical Practice (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 to provide compliance advice

Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents

Manage study-specific Clinical Study Audit Plans (CSAP) compliance for the assigned program by using a risk-based approach for Corcept clinical studies

Review and approve investigational product (IP) temperature excursions to ensure release or rejection of IP on time

Lead continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellence

Manage and support inspection readiness activities for GCP

Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigative site inspections, and contract research organization (CRO) inspections

Support GMP, GLP, and PV inspections

Lead clinical non-compliance event investigations and CAPA implementation

Perform quality metric analysis for clinical QA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data

Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies as related to GCPs. Maintain the GCP regulatory surveillance program

Provide cross-training development opportunities to QA team members, and mentor/coach junior QA team members upon request or as an assigned supervisor

Qualification

Clinical Quality AssuranceClinical Practice (GCP)Clinical research experienceQuality Systems knowledgeMicrosoft Office proficiencyContinuous improvementMentoring skills

Required