Director, Quality Assurance

Danaher Corporation•Coralville, IA

1d•Onsite

About The Position

The Director of Quality Assurance Operations is responsible for creating, implementing, and maintaining Quality and release processes that comply with foreign and domestic regulatory and statutory requirements. The role provides strategic direction, vision, and tactical leadership to drive continuous improvement. It leads enterprise-wide Quality Assurance strategy, governance, and risk management, advancing transformational improvements and business results through cross-functional leadership, executive influence, and multi-site accountability. The position owns the enterprise Quality Assurance strategy and Quality Management System (QMS), serving as the senior quality authority for enterprise decisions involving product quality, regulatory compliance, inspections, customer relationships, quality agreements, product disposition, and significant business risks. It establishes governance, performance metrics, and risk management frameworks; leads enterprise quality programs; and drives quality-system modernization, inspection readiness, quality culture, and adoption of industry best practices. The Director leads and develops a multi-site Quality organization and partners with executive leadership and cross-functional stakeholders to support strategic priorities, resource allocation, organizational capability, and quality improvements across the product lifecycle. This on-site role is part of Quality Assurance/Regulatory Affairs in Coralville, Iowa, and reports to the Senior Director of Quality Assurance. Travel may be up to 15%, including occasional overnight travel.

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 Quality Management Systems.
Direct experience with regulatory audits, including direct interface with inspectors.
Experience in regulated industries such as medical devices, biotechnology, pharmaceuticals, or aerospace.
Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) from development through commercial application.
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.
Ability to comply with applicable safety standards and procedures, including use of required PPE when visiting laboratories or manufacturing environments.

Nice To Haves

Strong knowledge of FDA and EU regulations regarding the manufacture of biologics, including 21 CFR Parts 210, 211, and 610 and EudraLex Volume 4, including regulatory inspection or support experience.
Strong analytical, problem-solving, and presentation skills.
Flexibility and ability to prioritize and manage multiple tasks simultaneously.
Experience creating and managing timelines and budgets, identifying risks, and planning contingencies.

Responsibilities

Own the enterprise Quality Assurance strategy and Quality Management System, aligning quality, compliance, and risk management objectives with business growth, customer expectations, and global regulatory requirements.
Serve as the senior quality authority for enterprise decisions involving product quality, regulatory compliance, inspections, customer relationships, quality agreements, product disposition, and significant business risks.
Establish enterprise-wide quality governance, performance metrics, and risk management frameworks across multiple sites and business units.
Lead quality programs covering CAPA, deviations, change control, complaints, investigations, supplier quality, batch release, and continuous improvement.
Drive quality transformation through quality-system modernization, inspection readiness, quality culture, and adoption of industry best practices.
Lead and develop a multi-site Quality organization; partner with executive leadership to influence strategic priorities, optimize resources, build organizational capability, and support long-term business objectives.
Collaborate with manufacturing, supply chain, regulatory affairs, Quality Control, and other departments to align on quality objectives, resolve issues, and drive compliant improvements across the product lifecycle.
Travel up to 15% of the time, including occasional overnight travel.
Work in an office environment using standard computer equipment and comply with applicable safety standards, including required PPE when visiting laboratories or manufacturing environments.