Quality Assurance Manager

Job Summary

Overseeing quality activities at contract manufacturing organizations, the full-time salaried Manager, Quality Assurance, External Manufacturing will ensure compliance with cGMP standards, drive performance through KPIs, and lead batch disposition while collaborating cross-functionally to resolve complex manufacturing and quality issues.

Key responsibilities:

• Provide Quality Assurance oversight of Contract Manufacturing Organizations (CMOs)
• Develop and report metrics and key performance indicators (KPIs) to evaluate CMO performance
• Lead polysaccharide batch disposition activities and review critical GMP documentation

Required qualifications:

• Bachelor's degree in chemistry, biology, pharmacy, engineering, or a related scientific discipline
• Minimum 5 years of experience in managing CMO quality and quality systems within the pharmaceutical, biotechnology, or life sciences industry
• Thorough knowledge of cGMP, ICH guidelines, and international pharmaceutical quality standards
• Experience in batch record review, deviations, and Out of Specification (OOS) investigations
• Strong leadership and management skills with a focus on process improvement