Director of Quality Operations leading US plasma donor centers compliance with FDA and PPTA regulations. Overseeing quality operations and maintaining strong quality culture across the organization.
Responsibilities
Ensure all plasma donor centers comply with FDA and PPTA regulations
Lead and develop a national Quality Operations team
Ensure effective communication and collaboration with various departments
Maintain audit and inspection readiness across all centers
Oversee investigations, deviations, CAPAs, and product quality issues
Establish and track quality metrics, KPIs, and trends for Donor Centers
Promote a proactive quality mindset with strong ownership at Donor centers
Requirements
Bachelor’s in Life Sciences, Pharmacy, Biology, Nursing or related field (required)
Master’s degree preferred
Typically requires 10 years in GxP or plasma/biologics Quality roles
5+ years leading multi-site Quality Operations teams
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