Senior Client Quality Manager- IDT

Location: On-site in Coralville, Iowa, United States

Company

hirify.global’s IDT operating company provides CDMO services that support the development of genomic medicines and other life sciences products.

What you will do

• Oversee quality manufacturing, testing, and product release activities for client-specific products.
• Provide daily management and leadership for quality-related functions.
• Set quality core team goals aligned with customer requirements and Customer Focused Team objectives.
• Partner with Quality Assurance and Quality Control leadership to improve team performance, safety, quality, and customer service.
• Support customer audits, visits, and conference calls, and develop systemic corrective actions for quality events and deviations.
• Lead proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design in compliance with cGMP requirements.

Requirements

• Bachelor of Science degree.
• At least 9 years of CDMO and/or customer-facing quality experience in a regulated or GMP-compliant environment.
• Experience leading projects.
• Exposure to regulatory agency inspections or audits, including FDA, notified body, or ISO audits.
• Ability to work on-site in Coralville, Iowa.

Nice to have

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

Culture & Benefits

• Work within a quality-focused, collaborative, and continuous-improvement culture.
• Health care benefits and paid time off.
• Equal opportunity workplace with reasonable accommodation support for candidates and employees with disabilities.