About this opportunity
Aerogen lists this Senior Director of Quality opportunity in morrisville, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
About Aerogen
Aerogen is headquartered in the vibrant city of Galway, Ireland, with offices around the world. It is the world leader in acute care aerosol drug delivery and has received multiple MedTech awards, including the Galway Chamber Company of the Year 2025 and eleven awards of the Zenith Award for Respiratory Care Excellence in North America. With a global team representing 54 nationalities, Aerogen is committed to improving patient care and delivering better patient outcomes for more than 30 million patients across 80 countries.
What is the role?
The Senior Director of Quality Assurance is responsible for developing and maintaining quality business strategy and a quality management system compliant with FDA drugs, biologics, and combination product regulations, with awareness of ISO 13485. This person will establish cross‑functional roles and responsibilities, lead an internal QA organization of 3–4 individuals and strategic consultants, and signify authorization from Quality for control documentation and final product disposition. Responsibilities include investigations and resolution of product quality and compliance issues at approved service providers, oversight of clinical quality assurance (GCP), and support of the company’s research and development programs. The position is hybrid, located in the Morrisville, NC office, and reports to the Aerogen Pharma CEO.
Key responsibilities
Develop and implement end‑to‑end quality assurance policies, procedures, and guidelines that comply with global regulatory standards (e.g., FDA, EMA, ICH).
Maintain SOPs and quality systems in alignment with changing business and regulatory requirements.
Provide leadership for the qualification of all GxP service providers.
Develop processes and systems to review and approve documentation related to manufacturing, analytical testing, labeling, and other quality activities.
Oversee quality investigations performed internally and at third‑party sites for drug, biologics, and medical devices.
Conduct risk assessments, identify potential quality issues, and implement mitigation strategies.
Establish regular internal audits of processes, documentation, and systems to ensure compliance with established quality systems.
Coordinate and participate in external audits and inspections, ensuring readiness and effective response to audit findings.
Maintain quality agreements with external manufacturing organizations.
Lead supplier qualification activities.
Provide sponsor batch review and release of drug/biological product and oversight of medical device release.
Direct other quality staff to support company activities.
Collaborate with the development team working with medical device suppliers, CDMOs and CMOs.
Manage the training program and documentation.
Manage the QA document management system.
Education and experience
Experience with Quality Management Systems implementation and maintenance.
A minimum of a bachelor’s degree in a scientific discipline.
At least 10 years’ experience in the biopharmaceutical industry.
At least 10 years of experience in Quality Assurance with a thorough understanding of cGMP.
Direct experience with health authority inspections.
Key skills
Experience with electronic documentation systems is a plus.
Laboratory QC experience is a plus.
Benefits
Competitive bonus plan.
Above‑market life insurance.
Opportunities for development and professional growth.
"Aerogen Connect" – an employee‑led program that helps global teams unite and have fun.
Donation of 1% of profits and time to charities and organizations.
Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. If you have difficulty using our application process, please contact us via email at
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Worksite address
morrisville, NC, 27560, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.