Quality Assurance Manager

Job Summary

To ensure compliance with quality standards, the full-time salaried Quality Assurance Manager will oversee the QA review and approval of technical documents and Quality Management System records for GMP analytical methods related to biologics and small molecules, collaborating with analytical and operational teams to address protocol deviations and implement continuous improvement initiatives.

Key responsibilities

• Provide QA review and approval of technical documents and QMS records throughout the product lifecycle
• Collaborate with relevant teams to resolve protocol deviations and manage CAPAs related to analytical methods
• Assist in the development and implementation of continuous improvement initiatives for Quality and QC functions

Required qualifications

• Minimum of 5 years of experience in Biologics and/or Small Molecule Quality Assurance or Quality Control
• Experience with electronic document and quality management systems (e.g., DCA, Veeva, Trackwise)
• Working knowledge of QC, QA, and analytical method development or validation functions
• Understanding of FDA guidelines and GxP regulations
• Previous experience in QC laboratory-facing QA activities is highly desirable