Associate Director Quality Assurance

Job Summary

Launching a high-impact, 2-year contract, the remote Associate Director Quality Capital Programs will provide critical quality assurance oversight for a major sterile campus project, ensuring compliance with GMP and contamination control from design through commissioning and qualification.

Key responsibilities

• Lead quality oversight and GMP Design Review Risk Assessments for sterile manufacturing capital programs
• Act as the primary Quality representative on cross-functional engineering and project teams to uphold contamination control principles
• Standardize GMP design review templates and integrate regulatory compliance feedback into the corporate quality system

Required qualifications

• Bachelor's or Master's degree in Microbiology, Science, or an Engineering-related discipline
• Minimum 10 years of experience in aseptic manufacturing and QC Microbiology
• Comprehensive understanding of biological/pharmaceutical technologies and quality assurance mindsets
• Strong knowledge of pharmaceutical regulatory requirements (FDA, EMEA, EU GMPs, ICH Q9, and PIC/S)
• Demonstrated experience with risk-based qualification methodologies