Senior Manager/Associate Director, QA Investigations and Quality Projects

Corcept Therapeutics seeks a Senior Manager/Associate Director to lead quality investigations, manage deviations and corrective actions, and drive cross-functional quality projects. The role partners with Operations, Manufacturing, Supply Chain, and Regulatory Affairs to ensure investigation quality, root cause analysis, and sustainable corrective actions aligned with GMP standards.

Responsibilities

• Lead quality investigations for deviations, complaints, temperature excursions, and audit findings with structured root cause analysis
• Develop and manage CAPA plans addressing root cause with clear owners, timelines, and measurable outcomes
• Serve as project manager for quality initiatives, process improvements, and cross-functional compliance projects
• Coordinate investigation teams and prepare documentation, summaries, and executive updates for management and regulatory review
• Evaluate product quality impact, track milestone closure, and identify recurring issues for process improvement recommendations

Requirements

• Strong technical writing and investigation documentation skills
• Sound judgment in quality risk assessment and compliance decision-making
• Excellent project management, prioritization, and follow-through abilities
• Ability to influence cross-functional teams without direct authority
• Strong communication skills with internal and external stakeholders
• Experience with root cause analysis tools and GMP expectations