Senior Client Quality Leader – On-Site Life Sciences CDMO

Radiometer; Fargo (ND); On-site; USD 90,000 - 130,000; Full time

Job summary

Aldevron, a Danaher operating company, seeks a Senior Client Quality Manager to lead quality activities for client-specific product releases. The role anchors with the Quality Assurance Organization in Fargo, ND and works on-site within the client-focused team to drive continuous improvement and regulatory readiness.

You will oversee risk assessments, collaborate with QA/QC, and enable performance and safety standards across GMP-compliant processes while partnering with customers and internal

Qualifications

• Bachelor of Science required; 9+ years CDMO or customer-facing quality experience.
• Experience in regulated or GMP environments and leading projects.
• Exposure to federal inspections (FDA, ISO, etc.) and quality certifications a plus.

Responsibilities

• Provide daily management and leadership to drive excellence in quality related functions.
• Create quality core team goals aligned with Customer Focused Team goals and customer requirements.
• Partner with Quality leadership to facilitate the daily quality team performance to ensure goals and objectives are met and to build a culture of safety, quality, performance, customer service and continuous improvement.
• Provide support for customer audits, visits and conference calls.
• Work with Customer Focused Team to develop systemic corrective actions to any deviations / Quality Events noted or discovered.
• Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design in compliance with Aldevron and cGMP policies, procedures, rules, and regulations.

Skills

Quality leadership

GMP compliance

Regulatory inspections experience

Project management

Education

Bachelor of Science

Tools

FMEA

Quality by Design

CAPA

Job description

Aldevron, a Danaher operating company, seeks a Senior Client Quality Manager to lead quality activities for client-specific product releases. The role anchors with the Quality Assurance Organization in Fargo, ND and works on-site within the client-focused team to drive continuous improvement and regulatory readiness.

You will oversee risk assessments, collaborate with QA/QC, and enable performance and safety standards across GMP-compliant processes while partnering with customers and internal