Quality Client Representative

Responsibilities

• Serve as the primary quality contact for assigned clients both internally and externally
• Manage client project quality updates and reviews with management levels
• Deliver accurate and timely quality decisions regarding client projects and requests
• Escalate quality issues to the Quality Manager or Director for corrective action
• Author, drive, or approve quality documents as the project representative
• Coordinate with Program Managers and Manufacturing Representatives to align facility representation
• Represent Quality in required Project Client Meetings
• Maintain Project Files, including tracking quality interactions and reporting metrics
• Lead quality agreement contract negotiations and continuous improvement activities

Requirements

• Bachelor's degree in a science-related field with 5 years of pharmaceutical industry experience
• Master's degree with 3 years of pharmaceutical industry experience
• Familiarity with quality operating procedures and regulatory requirements for pharmaceutical and biological products
• Knowledge of worldwide regulatory requirements
• Proficiency in Microsoft Word, Excel, and Outlook
• Experience with enterprise software such as D365, Veeva, Blue Mountain, or Trackwise

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring sterile injectable products to market, including biologics, small molecules, and vaccines.