Head of Quality Assurance & Global Compliance

Integrated DNA Technologies; Coralville (IA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Director of Quality Assurance Operations to lead enterprise QA strategy and the Quality Management System on-site in Coralville, IA. You will drive regulatory compliance, governance and cross-site improvements.

The ideal candidate has 10+ years in quality, 3+ years in leadership, strong GMP and FDA/EU CFR 820 and ISO 13485 expertise, and a proven ability to partner with manufacturing, regulatory affairs and supply chain to

Qualifikationen

• 10+ years of relevant quality experience.
• 3+ years in a lead or managerial role.
• Experience with Quality Management Systems (QMS) across domains.
• Direct experience with regulatory audits and inspectors.
• Experience in regulated industries (biotech/pharma/medical devices).
• Strong GMP knowledge for development through commercial applications.
• Knowledge of FDA and EU regulations (CFR 820, ISO 13485).

Aufgaben

• Own enterprise QA strategy and QMS governance.
• Serve as senior quality authority for product quality and regulatory readiness.
• Establish enterprise quality governance and risk management frameworks.
• Lead CAPA, deviations, change control, complaints, investigations, supplier quality, batch release, and continuous improvement.
• Drive modernization of quality systems, inspection readiness, quality culture, and cost of quality.
• Lead and develop a multi-site Quality organization with senior leadership alignment.
• Collaborate with manufacturing, regulatory affairs, Quality Control and supply chain to drive improvements across the product lifecycle.

Kenntnisse

Quality leadership

Regulatory audits

GMP knowledge

Quality systems

Tools

QMS software

Jobbeschreibung

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Director of Quality Assurance Operations to lead enterprise QA strategy and the Quality Management System on-site in Coralville, IA. You will drive regulatory compliance, governance and cross-site improvements.

The ideal candidate has 10+ years in quality, 3+ years in leadership, strong GMP and FDA/EU CFR 820 and ISO 13485 expertise, and a proven ability to partner with manufacturing, regulatory affairs and supply chain to