Senior GMP & Regulatory Audit Lead

Radiometer; Coralville (IA); On-site; USD 83,000 - 105,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Paid time off

Job summary

Danaher’s IDT division seeks a Quality Assurance professional to lead all aspects of GMP and quality audits, planning, execution, report issuance, CAPA reviews, and inspection closeout. You will partner with cross‑functional teams to strengthen regulatory compliance and product quality, and ensure readiness for FDA, ISO, and other regulatory inspections.

Responsibilities include coordinating audit logistics, maintaining audit documentation, and developing tools to improve efficiency while

Qualifications

• 4+ years in quality, compliance, or auditing in a cGMP environment
• Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs or related field

Responsibilities

• Lead or participate in audits/inspections by FDA, ISO, Notified Bodies, or equivalent regulators
• Maintain knowledge of cGMP, ICH Q10, ISO 13485, 21 CFR 210/211, and related regulatory standards
• Ensure audit readiness and develop corrective actions with cross-functional teams
• Travel may be required up to 20% with valid driver's license

Skills

Audit leadership

Regulatory knowledge

GXP compliance

CAPA management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Engineering/Quality/Regulatory Affairs

Job description

Danaher’s IDT division seeks a Quality Assurance professional to lead all aspects of GMP and quality audits, planning, execution, report issuance, CAPA reviews, and inspection closeout. You will partner with cross‑functional teams to strengthen regulatory compliance and product quality, and ensure readiness for FDA, ISO, and other regulatory inspections.

Responsibilities include coordinating audit logistics, maintaining audit documentation, and developing tools to improve efficiency while