Manager, Quality Assurance Compliance

Corcept is a biopharmaceutical company leading the way in the research and development of cortisol modulators. The Manager, Quality Assurance Compliance role ensures compliance with GxP guidelines across all supplier and vendor management relationships, responsible for supplier quality activities, managing supplier audits, and partnering with internal and external stakeholders to drive continuous improvement.

Requirements

• Support the qualification, monitoring and requalification process, including risk assessments of suppliers
• Participate in GxP vendor qualification through risk-based audits and performance criteria
• Maintain and tracks key compliance metrics during management reviews to help ensure internal and external adherence to quality compliance and/or improvement opportunities
• Manage the audit lifecycle such as scheduling, planning, issuing agendas, issuing reports, evaluating responses, requesting clarification, issuing Corrective Action (CA), Preventive Action (PA) and closing audits in Veeva
• Develops external audit schedule for QA Ops
• Ensure all suppliers comply with Corcept’s expectation, internal procedures and regulatory requirements. (FDA, EMA, and other international health authorities)