Director OF Quality

About Aerogen: Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards, including being named Galway Chamber Company of the Year 2025, and an eleven-time winner of the Zenith Award for Respiratory Care Excellence in North America, our employees make a difference to patients’ lives every day, having reached over 30 million patients in more than 80 countries. Today, Aerogen is powered by a global team representing 54 nationalities, working together with a shared commitment to improving patient care. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way by finding innovative solutions to even the most complex problems, all in the name of delivering better patient outcomes. Our business continues to grow rapidly across the globe and, as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours, and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter. What is the role? The Senior Director of Quality Assurance is responsible for development and maintenance of the quality business strategy and quality management system compliant with FDA drugs, biologics and combination products, with an awareness of ISO13485. This person will establish cross‑functional roles and responsibilities and have accountability for execution of all strategic imperatives. The role will lead an internal QA organization of 3‑4 individuals and strategic consultants. The Sr. Director of Quality will direct the development, implementation and maintenance of quality assurance systems and activities. This person will provide the signatory authorization from Quality for control documentation and final product disposition. They will be responsible for the investigations and resolution of product quality and compliance issues seen at approved service providers. They will have oversight of clinical quality assurance (GCP). This position is a hybrid role, located in the Morrisville, NC office, and is a key member of the leadership team that contributes to and supports the company’s research and development programs. This position reports to the Aerogen Pharma CEO. What are the 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/Quality Systems to keep them current with changing business and regulatory requirements. Provide leadership for the qualifications of all GxP service providers. Develop processes and systems to ensure review and approval of documentation related to manufacturing, analytical testing, labeling, and other quality‑related activities. Provide input and oversight of quality investigations performed internally and at all third parties for drug, biologics and medical devices. Ensure end‑to‑end risk assessments to identify potential quality issues and implement effective 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’s batch review and release of drug/biological product. Provide oversight of the release of the medical device. Direct other quality staff to support company activities. Participate in the company’s development team working with medical device suppliers, CDMOs and CMOs. Be responsible for the training program and documentation. Be responsible for the QA document management system. What education and experience are required? Experience with quality management systems implementation and maintenance. A minimum of a bachelor’s degree in a scientific discipline. A minimum of 10years’ experience in the biopharmaceutical industry. A minimum of 10years working in quality assurance with a thorough understanding of cGMP. Direct experience with health authority inspections. What key skills will make you great at the role? Experience with electronic documentation systems is a plus. Laboratory QC experience is a plus. What is it like to work at Aerogen? Our purpose is to transform patient lives and our ethos is #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non‑financial rewards and benefits. Here is an idea of what we offer: Competitive bonus plan. Above‑market life insurance. Opportunities for development and professional growth. Aerogen Connect – our employee‑led program that helps our global teams unite and have fun. We donate 1 % of profits and time to charities and organizations. Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. #J-18808-Ljbffr