Manager, Quality Assurance Operations

The Quality Assurance Operations Manager is responsible for a variety of operational activities pertaining to assuring product quality and compliance with the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution. This role will also be responsible for the oversight of 3PLs and work closely with the QPs to distribute products in EU. This is a remote role.

Responsibilities:

• Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
• Work cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations
• Perform review of executed batch records and test data and perform product disposition
• Review and approval of validation protocols and reports (e.g., process, method, etc.)
• Lead and support quality audit of contract service providers
• Develop, review, and revise Standard Operating Procedures (SOPs) to reflect current industry best practices and regulatory standards
• Generate and review Quality and Technical Agreements with Contract Service Providers (CSP)
• Perform quality trends analysis and reports, recommending continual improvements opportunities
• Support the management and growth of the Quality Assurance Operations team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team’s capabilities meet Corcept’s future needs
• Support the QP/RP to ensure timely disposition of batches
• Provide cross training development opportunities, mentor and coach junior QA team members

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong QMS experience in the EU and knowledge of EU country specific requirements
• 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:

• Bachelor’s or master’s 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

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