Senior Client Quality Lead — Life Sciences CDMO

Aldevron; Fargo (ND); On-site; USD 110,000 - 140,000; Full time

Job summary

Aldevron, a Danaher operating company in Fargo, ND, seeks a Senior Client Quality Manager to oversee all quality manufacture, testing and product release for client products. You will partner with QA/QC and lead the Customer Focused Team to achieve goals on time and within budget.

The role requires a BS and 9+ years in CDMO or customer-facing quality roles in regulated environments, with audits experience and formal quality certifications a plus. On-site position.

Qualifications

• Bachelor of Science, required.
• 9+ years of CDMO and (or) customer-facing experience in a Quality role with GMP environment and project leadership.
• Exposure to regulatory inspections or audits (FDA, ISO, etc.).
• Quality certifications a plus (e.g., ISO 9001, ASQ).

Responsibilities

• Provide daily management and leadership to drive quality functions.
• Align quality goals with customer-focused team objectives and requirements.
• Collaborate with Quality leadership to ensure safety, quality and continuous improvement.
• Support customer audits, visits and conference calls with systemic corrective actions.
• Apply FMEA, HACCP and Quality by Design to ensure compliance.

Skills

Quality leadership

Project management

Regulatory compliance

Audit support

Education

Bachelor of Science

Tools

FMEA

HACCP

Quality by Design

GMP

Job description

Aldevron, a Danaher operating company in Fargo, ND, seeks a Senior Client Quality Manager to oversee all quality manufacture, testing and product release for client products. You will partner with QA/QC and lead the Customer Focused Team to achieve goals on time and within budget.

The role requires a BS and 9+ years in CDMO or customer-facing quality roles in regulated environments, with audits experience and formal quality certifications a plus. On-site position.