Manager, Quality Operations

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . Corcept is seeking a Senior Manager/Associate Director, Quality Operations to provide strategic and operational Quality leadership across commercial and clinical pharmaceutical manufacturing, testing, validation, disposition, and supply activities. This individual will serve as a senior Quality representative for CMC programs and external manufacturing and testing partners, helping ensure product quality, regulatory compliance, patient safety, and timely execution of Quality Operations deliverables in accordance with global cGMP requirements. This is a hybrid role that typically requires on-site presence three days per week. Responsibilities: • Serve as a Quality Operations lead for complex CMC, commercial, and clinical supply programs by providing strategic quality direction, risk-based decision-making, and timely issue escalation • Provide quality oversight of contract manufacturing organizations, contract testing laboratories, suppliers, and other external partners to ensure compliance with approved procedures, regulatory expectations, and quality agreements • 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 activities, ensuring timely root cause analysis and effective corrective and preventive actions • Review and approve validation protocols and reports, including process validation, analytical method validation, cleaning validation, packaging validation, and shipping lane qualification, as applicable • Lead or support audits of suppliers, CLOs, CMOs, and service providers, including audit planning, execution, reporting, response evaluation, and follow-up of corrective actions • Develop, monitor, and communicate Quality metrics and trend reports to identify compliance risks, recurring issues, and opportunities for continuous improvement • Partner cross-functionally with CMC, Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Commercial teams to support submissions, inspections, product launches, and lifecycle management activities • Mentor and guide Quality Operations staff and cross-functional team members, as applicable, to strengthen technical capability, inspection readiness, and operational excellence Preferred Skills, Qualifications and Technical Proficiencies: • An understanding of pharmaceutical manufacturing, analytical testing, validation, quality systems, and global cGMP expectations for commercial and clinical products • Demonstrated ability to apply sound quality judgment, assess compliance risk, and make recommendations that support regulatory compliance, patient safety, product quality, and business continuity • Experience with batch record review, product disposition, deviation management, CAPA, change control, validation, supplier quality, and quality agreement oversight • Proven ability t