Senior Client Quality Manager (Biotech)

Location: On-site in Fargo, North Dakota, United States

Company

hirify.global’s Aldevron operating company provides CDMO services for genomic medicine and biological products.

What you will do

• Oversee quality manufacturing, testing, and product release activities for client-specific products.
• Lead daily quality functions and align quality core team goals with customer requirements.
• Partner with Quality Assurance and Quality Control leadership to improve team performance, safety, quality, and customer service.
• Support customer audits, visits, conference calls, and systemic corrective actions for quality events.
• Apply FMEA, HCCAP, and Quality by Design to conduct proactive quality assurance and risk assessments under cGMP requirements.

Requirements

• Bachelor of Science degree.
• 9+ years of CDMO or customer-facing quality experience in a regulated or GMP-compliant environment.
• Experience leading projects and exposure to regulatory inspections or audits, including FDA, notified body, or ISO audits.
• Ability to work on-site in Fargo, North Dakota.

Nice to have

• Current or past quality certifications such as ISO 9001 or ASQ.
• Experience in cell and gene therapy or biological manufacturing.

Culture & Benefits

• Mission-driven work supporting life sciences, diagnostics, biotechnology, and genomic medicine.
• Focus on continuous improvement through the hirify.global Business System.
• Health care programs and paid time off.
• Equal opportunity and reasonable accommodation support for applicants and employees with disabilities.