Director, Quality Assurance

Danaher•Coralville, IA

10h•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 and vision alongside the tactical leadership needed to drive continuous improvement. It leads enterprise-wide Quality Assurance strategy, governance, and risk management, using cross-functional leadership, executive influence, and multi-site accountability to drive transformation and business results. The Director owns 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. As the senior quality authority for enterprise decisions, the role addresses product quality, regulatory compliance, inspections, customer relationships, quality agreements, product disposition, and significant business risks. The Director establishes governance, performance metrics, and risk management frameworks; leads enterprise quality programs; modernizes quality systems and inspection readiness; and develops a multi-site Quality organization in partnership with executive leadership. This position reports to the Sr. Director of Quality Assurance and is part of Quality Assurance/Regulatory Affairs. It is an onsite role in Coralville, Iowa, USA, with travel of up to 15% of the time, including occasional overnight travel. The role involves working in an office and using standard computer equipment, and requires compliance with applicable safety procedures, including use of required PPE when visiting laboratories or manufacturing environments.

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 a regulated industry such as medical devices, biotechnology, pharmaceuticals, or aerospace.
Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in 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 CFR 820 and ISO 13485, and 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 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 enterprise quality programs, including CAPA, deviations, change control, complaints, investigations, supplier quality, batch release, and continuous improvement.
Drive quality transformation through modernization of quality systems, inspection readiness, quality culture, and adoption of industry best practices.
Lead and develop 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 manufacturing, supply chain, regulatory affairs, Quality Control, and other departments to align on quality objectives, resolve quality-related issues, and drive compliant improvements across the product lifecycle.