Clinical QA Lead: GCP Audits & Compliance

Corcept Therapeutics; Redwood City (CA); Hybrid; USD 173,000 - 204,000; Full time

Job summary

The Senior Manager of Clinical Quality Assurance (CQA) at Corcept Therapeutics leads day-to-day quality operations and compliance activities to support our clinical studies. This hybrid role requires on-site presence at least 3 days per week at our Redwood City headquarters.

The role focuses on GCP audits, risk-based oversight, inspection readiness, and collaboration with study teams to ensure regulatory compliance throughout the study lifecycle.

Qualifications

• BS/BA in science or related field or equivalent experience.
• 8+ years clinical research experience, 2+ years CQA experience preferred.
• Thorough understanding of Quality Systems that support GCP activities.
• Experience leading complex quality investigations, root cause analysis and CAPA.
• Experience developing GCP processes for best industry practices.

Responsibilities

• 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 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
• 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 studies in alignment with study milestones
• Support clinical inspections conducted by regulatory agencies, 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)
• Maintain a contemporary knowledge of agency and industry trends, standards, regulations and methodologies related to GCP
• Provide cross-training development opportunities to CQA team, and mentor/coach junior QA team members
• Some travel required

Skills

Quality Systems

GCP Audits

Audit Leadership

Risk Management

CtQ Risk Focus

SOP Review

Mentor/Coach

Education

BS/BA in science or related field

Job description

The Senior Manager of Clinical Quality Assurance (CQA) at Corcept Therapeutics leads day-to-day quality operations and compliance activities to support our clinical studies. This hybrid role requires on-site presence at least 3 days per week at our Redwood City headquarters.

The role focuses on GCP audits, risk-based oversight, inspection readiness, and collaboration with study teams to ensure regulatory compliance throughout the study lifecycle.