Quality Assurance Operations Lead

Job Summary

Managing quality-related activities and projects, the full-time salaried QA Operations Lead will oversee manufacturing operations at the Angleton site, ensuring GxP compliance and supporting quality oversight in radiopharmaceutical manufacturing.

Key responsibilities:

• Provide manufacturing quality oversight across production, quality control, and supply chain departments to ensure compliance with ITG quality systems
• Lead FDA/Regulatory interactions for site activities, ensuring successful regulatory submissions and inspections
• Participate in writing and approving deviations, investigations, CAPA, change control, and complaint reports

Required qualifications:

• Bachelor's degree in Life Sciences, Quality Management, or a related field
• 5+ years of experience in a quality assurance role, specifically in GxP manufacturing operations
• Technical understanding of manufacturing, quality, and regulatory requirements
• Experience in writing and reviewing standard operating procedures (SOPs) and specifications
• Willingness to work with radioactive materials and adhere to strict safety protocols