Director, Quality Assurance
Danaher Corporation
Summary
The 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.
Job description
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:
- 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:
- 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
Requirements
- At least 10 years of relevant experience in a quality position
- At least 3 years of 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 principles and current Good Manufacturing Practices (GMPs) in a development through commercial application
- 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
- 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
- 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
Benefits
- Health care program
- Paid time off
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.