Manager, Quality Operations

The role

This role provides strategic and operational Quality leadership across commercial and clinical pharmaceutical manufacturing, testing, validation, disposition, and supply activities. The individual serves as a senior Quality representative for CMC programs and external partners to ensure compliance and product quality.

What you will do

• Serve as a Quality Operations lead for complex CMC, commercial, and clinical supply programs
• Provide quality oversight of contract manufacturing organizations, contract testing laboratories, suppliers, and other external partners
• Review and approve GMP documentation including batch records, analytical data, investigations, deviations, CAPAs, change controls, validation documentation, and product disposition records
• Lead or oversee quality investigations related to manufacturing, testing, packaging, labeling, storage, distribution, and product release
• Review and approve validation protocols and reports
• Lead or support audits of suppliers, CLOs, CMOs, and service providers
• Develop, monitor, and communicate Quality metrics and trend reports
• Partner cross-functionally with CMC, Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Commercial teams
• Mentor and guide Quality Operations staff and cross-functional team members

Required qualifications

• Understanding of pharmaceutical manufacturing, analytical testing, validation, quality systems, and global cGMP expectations
• Ability to apply sound quality judgment and assess compliance risk
• Experience with batch record review, product disposition, deviation management, CAPA, change control, validation, supplier quality, and quality agreement oversight
• Ability to lead cross-functional teams and manage complex quality issues
• Experience leading or supporting regulatory inspections and internal or external audits
• Ability to author, review, approve, and improve SOPs, quality agreements, risk assessments, and technical reports
• Strong analytical, problem-solving, and communication skills
• Ability to manage multiple priorities independently in a fast-paced, matrixed environment
• Experience developing, analyzing, and presenting Quality metrics and trend reports
• Proficiency with Microsoft Word, Excel, PowerPoint, Visio, Smartsheet, and electronic quality management systems
• Bachelor’s or Master’s degree in science, engineering, pharmacy, or a related field
• 6+ years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, or other regulated life sciences industry

Nice to have

• Advanced degree preferred

Before you apply

• Applicants must be currently authorized to work in the United States on a full-time basis

About the company

Corcept is headquartered in Redwood City, California and has been focused on the science of cortisol for more than 25 years. The company's commercial portfolio includes treatments for hypercortisolism and oncology.