The Quality Operations Manager/Sr. Manager is responsible for managing a variety of operational activities to provide appropriate quality oversight of manufacturing activities at Corcept and Contract manufacturing Organizations (CMOs) by establishing and maintaining performance dialogue with suppliers including supplier evaluations and CMO/product/process risk assessments to ensure compliance for early phase development products through commercial products. The successful candidate will support the  manufacture, testing, control, validation, labeling, and release of Corcept clinical and commercial drug substance, drug product, and finished goods supplies ensuring the products are in compliance with current Good Manufacturing Practices (cGMP) and are of the appropriate quality for their intended use.

Responsibilities:

• Lead QA operations oversight of Corcept and external partners processes to support various Chemistry, Manufacturing and Controls (CMC) projects
• Provide cGMP compliance support and guidance to cross functional team
• Work cross-functionally with the CMC group to provide oversight and support and manage review and approvals of change controls, deviations, CAPAs, and SOPs internally and externally
• Review and approve Master Batch Record (MBR) and executed batch records (EBR) and test data, and perform product disposition in compliance with cGMP regulations, regulatory filings, and quality agreements
• Review and approval of validation protocols and reports (e.g., process, method, cleaning, etc.)
• Lead and support supplier qualification
• Perform regular update of Quality Agreements
• Perform quality trends analysis and reports, recommending continual improvements opportunities

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes
• Strong experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the release of pharmaceutical products
• Ability to work independently and communicate effectively with project team members and management groups and suppliers
• Work well in a project team environment with solid problem analysis and decision-making ability
• Ability to lead or support internal and external compliance audits of suppliers, CTLs, and CMOs
• Ability to work independently in addition to clearly and concisely communicate both in writing and verbally
• Ability to identify compliance risk and recommend mitigations
• Ability to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations
• Strong statistical mindset and metric presentation
• Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio
• Travel required

Preferred Education and Experience:

• BS or MS degree in science, engineering or related field
• At least 10 years in the bio/pharmaceutical industry
• At least 5-10 years in Quality Assurance
• Knowledge in application of 21CFR211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products

The pay range that the Company reasonably expects to pay for this headquarters-based position is $150,200 - $215,600; 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.