Director, Global Quality Assurance & Compliance

Radiometer; Coralville (IA); On-site; USD 140,000 - 190,000; Full time

Job summary

IDT, a Danaher operating company, seeks a Director of Quality Assurance Operations in the Coralville, IA area. The role leads enterprise QA strategy and QMS, ensuring alignment with global regulatory requirements, quality governance, and continuous improvement across multiple sites.

You will drive CAPA, deviations, and supplier quality while partnering with executive leadership to meet business objectives. The ideal candidate has 10+ years in quality roles with 3+ years in leadership, deep GMP

Qualifications

• At least 10 years of relevant experience in a quality position.
• At least 3 years of that experience in a lead, supervisory or managerial position.
• Experience in a variety of areas of the Quality Management Systems.
• Direct experience with regulatory audits, including direct interface with inspectors.
• Experience within regulated industries such as medical devices, biotechnology, pharmaceuticals, or aerospace.
• Knowledge and expertise in GMPs in development through commercial application.
• Strong knowledge of FDA and EU regulations regarding biologics manufacturing and regulatory inspection experience preferred.
• Ability to travel up to 15% of the time, including overnight travel.
• Ability to work in an office environment and use standard computer equipment.
• Must comply with safety standards including PPE when visiting laboratories or manufacturing environments.

Responsibilities

• Own the enterprise Quality Assurance strategy and QMS, aligning quality objectives with growth and regulatory requirements.
• Serve as senior quality authority for product quality, regulatory compliance, inspections and risk management.
• Establish enterprise-wide quality governance, metrics, and risk management across sites.
• Lead enterprise quality programs (CAPA, deviations, change control, complaints, investigations, supplier quality, batch release).
• Drive quality transformation through modernization of systems, inspection readiness, and a culture of quality.
• Develop a multi-site Quality organization, partnering with executives to align priorities and resources.
• Collaborate with manufacturing, regulatory affairs, Quality Control and other departments to ensure cross-functional alignment.

Skills

Quality Leadership

GMP Knowledge

Regulatory Audits

FDA/EU Regulations

Travel Readiness

Cross-functional Collaboration

Job description

IDT, a Danaher operating company, seeks a Director of Quality Assurance Operations in the Coralville, IA area. The role leads enterprise QA strategy and QMS, ensuring alignment with global regulatory requirements, quality governance, and continuous improvement across multiple sites.

You will drive CAPA, deviations, and supplier quality while partnering with executive leadership to meet business objectives. The ideal candidate has 10+ years in quality roles with 3+ years in leadership, deep GMP