Senior Client Quality Manager

Aldevron, a Danaher operating company, seeks a Senior Client Quality Manager to oversee quality manufacturing, testing, and product release for CDMO clients in Fargo, North Dakota. The role combines quality leadership with cross-functional collaboration to drive continuous improvement and ensure regulatory compliance.

Responsibilities

• Lead and manage quality functions and team performance to meet goals and objectives
• Establish quality team goals aligned with customer-focused team and client requirements
• Support customer audits, visits, and conference calls with systemic corrective actions
• Conduct proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design
• Partner with quality leadership to build culture of safety, quality, and continuous improvement

Requirements

• Bachelor of Science degree
• 9+ years CDMO and/or customer-facing quality experience in regulated GMP environments
• Project leadership experience in quality functions
• Exposure to regulatory inspections or audits (FDA, notified bodies, ISO)
• Current or past quality certifications such as ISO 9001 or ASQ preferred
• Cell and gene therapy or biological manufacturing experience preferred