Director of Quality Assurance Operations is responsible for the creation, implementation and maintenance of all Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic direction and vision as well as the tactical leadership necessary to consistently improve. Leads enterprise-wide Quality Assurance strategy, governance, and risk management, driving transformational improvements and business results through cross-functional leadership, executive influence, and multi-site organizational accountability
This position reports to the Sr. Director of Quality Assurance and is part of Quality Assurance/Regulatory Affairs located in USA Coralville IA and will be an on-site role.
In this role, you will have the opportunity to:
• Own the enterprise Quality Assurance strategy and Quality Management System (QMS), aligning quality, compliance, and risk management objectives with business growth, customer expectations, and global regulatory requirements.
• Serves as the senior quality authority for enterprise decisions involving product quality, regulatory compliance, inspections, customer relationships, quality agreements, product disposition, and significant business risks.
• Establishes enterprise-wide quality governance, performance metrics, and risk management frameworks to drive compliance, operational excellence, and data-driven decision making across multiple sites and business units.
• Leads enterprise quality programs, including CAPA, deviations, change control, complaints, investigations, supplier quality, batch release, and continuous improvement to ensure sustainable business performance.
• Drives quality transformation through modernization of quality systems, inspection readiness, quality culture, and adoption of industry best practices to improve scalability, compliance, and cost of quality.
• Leads and develops a multi-site Quality organization, partnering with executive leadership to influence strategic priorities, optimize resource allocation, build organizational capability, and achieve long-term business objectives.
• Collaborate with stakeholders: Work closely with manufacturing, supply chain, regulatory affairs, Quality Control, and other relevant departments to ensure alignment on quality objectives, resolve quality-related issues, and drive improvements across the entire product lifecycle in a compliant manner.
The essential requirements of the job include:(NOTE For Hiring Manager: Please reference the 3-5-7 Job Requirements Model)
• At least 10 years of relevant experience in a quality position, required
• 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, required
• Direct experience with regulatory audits, including direct interface with inspectors, required
• Experience within regulated industries such as medical devices, biotechnology, pharmaceuticals, or aerospace
• Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, required
• Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and EudraLex Vol. 4), including regulatory inspection or support experience, preferred
Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
• Ability to travel up to 15% of the time, including occasional overnight travel.
• Ability to work in an office environment and use standard computer equipment.
• Must be able to comply with all applicable safety standards and procedures, including the use of required PPE when visiting laboratories or manufacturing environments.
It would be a plus if you also possess previous experience in:
• Strong analytical skills, problem solving ability and presentation skills
• Flexibility and ability to prioritize and manage multiple tasks simultaneously
• Well-versed in creating and managing timelines and budgets, identifying risks and contingency planning
IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
