Senior Quality Operations Lead – CMC & Compliance

Regulatory Jobs; Redwood City (CA); Hybride; USD 161 000 - 189 000; Plein temps

Résumé du poste

Corcept Therapeutics, headquartered in Redwood City, California, seeks a strategic Quality Operations leader to provide oversight across commercial and clinical manufacturing, testing, validation, and product disposition in line with global cGMP.

The role partners with CMC, Regulatory, and Supply Chain, leads audits, CAPAs, and continuous improvement, and mentors QC staff; on-site three days per week as hybrid.

Qualifications

• Bachelor’s or Master’s degree in science, engineering, pharmacy, or a related field; advanced degree preferred
• 6+ years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, or other regulated life sciences industry
• Strong working knowledge of 21 CFR Parts 210/211, 21 CFR Part 11, EU GMP, ICH guidelines, and other applicable global regulations governing development, manufacture, testing, release, distribution, and control of pharmaceutical products

Responsabilités

• Serve as a Quality Operations lead for complex CMC, commercial, and clinical supply programs with strategic quality direction
• Provide quality oversight of contract manufacturing organizations and suppliers to ensure compliance with procedures, regulatory expectations, and quality agreements
• Review and approve GMP documentation including batch records, investigations, CAPAs, validation documentation, and product disposition records
• Lead or oversee quality investigations related to manufacturing, testing, packaging, labeling, storage, distribution, and product release activities
• Review and approve validation protocols and reports including process and method validation and cleaning validation
• Lead or support audits of suppliers and service providers, including planning, execution, and follow-up of corrective actions
• Develop, monitor, and communicate Quality metrics and trend reports for compliance risk and continuous improvement
• Collaborate with CMC, Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Commercial teams for submissions, inspections, and lifecycle management
• Mentor Quality Operations staff and cross-functional teams to strengthen capability and inspection readiness

Connaissances

Quality leadership

Regulatory inspections

Cross-functional leadership

Quality systems

Risk assessment

Analytical skills

SOPs

Formation

Bachelor’s or Master’s degree in science/engineering/pharmacy

Outils

MS Word

Excel

PowerPoint

Visio

Smartsheet

Electronic quality management systems

Description du poste

Corcept Therapeutics, headquartered in Redwood City, California, seeks a strategic Quality Operations leader to provide oversight across commercial and clinical manufacturing, testing, validation, and product disposition in line with global cGMP.

The role partners with CMC, Regulatory, and Supply Chain, leads audits, CAPAs, and continuous improvement, and mentors QC staff; on-site three days per week as hybrid.