Manager, Quality Operations

Corcept Therapeutics seeks a senior quality leader to oversee operations across commercial and clinical pharmaceutical manufacturing, testing, and supply chains. The role combines strategic direction with hands-on oversight of contract manufacturers, regulatory compliance, and quality investigations to ensure product safety and timely delivery.

Responsibilities

• Provide strategic quality direction and risk-based decision-making for CMC and commercial programs
• Oversee compliance of contract manufacturers, testing labs, and suppliers with approved procedures and regulations
• Lead quality investigations, root cause analysis, and corrective actions for manufacturing and product release issues
• Review and approve GMP documentation including batch records, validation studies, and change controls
• Plan and execute audits of suppliers and external partners, with follow-up on remediation

Requirements

• Expertise in pharmaceutical manufacturing, analytical testing, and cGMP requirements
• Experience managing contract manufacturing organizations and external testing partners
• Proficiency reviewing batch records, investigations, deviations, and validation documentation
• Track record leading quality audits and corrective/preventive action programs
• Cross-functional collaboration skills with regulatory, technical, and supply chain teams
• Ability to mentor quality operations staff and drive continuous improvement