Quality Client Representative

Responsibilities

• Serve as the primary quality contact for assigned clients both externally and internally
• Manage client project quality updates and reviews with all levels of management
• Deliver accurate and timely quality decisions regarding client projects and requests
• Escalate quality issues to departmental managers or the Quality Director for corrective action
• Author, drive, or approve quality documents as the Quality representative
• Partner with Program Managers and Manufacturing Representatives to coordinate projects and provide consistent quality information
• Represent Quality in required Project Client Meetings
• Maintain Project Files, including recording and tracking quality interactions and 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, or a Master's degree with 3 years of 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
• Ability to use enterprise software such as JDE, BPLM, Pilgrim, 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.