Quality Assurance Manager

Job Summary

Overseeing quality oversight and approval of deviation assessments and investigations, the full-time salaried Quality Assurance Manager will ensure compliance with regulations and BMS policies at the Summit Cell Therapy Facility while driving effective deviation processes and continuous improvement initiatives.

Key responsibilities

• Review and approve complex investigations, CAPAs, and effectiveness checks related to manufacturing processes
• Author and review technical reports to support the deviations program, ensuring corrective actions address root causes
• Coach employees on deviations and investigations while liaising with global teams to resolve issues

Required qualifications

• Bachelor's degree in a STEM field preferred, or equivalent combination of education and experience
• 6+ years of experience in a regulated industry, with at least 2 years of deviation experience preferred
• Demonstrated proficiency in root cause analysis tools and electronic systems
• Ability to interpret complex data and provide critical feedback on proposed CAPAs
• Excellent technical writing skills for preparing reports and presenting data to management