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 to lead cross-functional teams, influence stakeholders, and manage complex quality issues with internal departments and external partners
- Experience leading or supporting regulatory inspections and internal or external audits, including inspection readiness, response preparation, and remediation activities
- Ability to author, review, approve, and improve SOPs, quality agreements, risk assessments, technical reports, and other controlled documentation
- Strong analytical, problem-solving, and communication skills, including the ability to present quality risks, metrics, and recommendations clearly to senior management
- Ability to manage multiple priorities independently in a fast-paced, matrixed environment while maintaining compliance, accountability, and attention to detail
- Experience developing, analyzing, and presenting Quality metrics and trend reports
- Proficiency with Microsoft Word, Excel, PowerPoint, Visio, Smartsheet, and electronic quality management systems
- Ability to travel up to 20%
Preferred Education and Experience:- 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 the development, manufacture, testing, release, distribution, and control of pharmaceutical products
The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,600 - $189,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
