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Quality Operations Associate Manager

Job Description:

The incumbent will be responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution.


Responsibilities:

  • Act as Quality lead and support in various 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 batch records and test records, and perform lot dispositions
  • Review and approval of validation protocols and reports (e.g., process, method, etc.)
  • Lead and support quality audit of suppliers, CLOs, and CMOs
  • Perform quality trends analysis and reports, recommending continual improvements opportunities


Requirements:

  • Strong technical knowledge of analytical and manufacturing technologies and processes
  • Strong experience with batch records 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, CLOs, and CMOs
  • Ability to identify compliance risk and recommend corrective actions.
  • 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.
  • Job requires 20% travel


Preferred Skills, Qualifications, or Technical Proficiencies:

  • BS or Master’s degree in science, engineering or related field
  • 10 years in the bio/pharmaceutical industry
  • 5-7 years in Quality Assurance
  • Knowledge in application of 21CFR211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, delivery, and control of pharmaceutical products.


If you are interested, please submit your resume by email to hr@corcept.com

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