Manager, Quality Operations
Corcept Therapeutics · Redwood City, CA
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Corcept Therapeutics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.