Senior Director of Quality

About Aerogen Pharma

Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.

We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world.

Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.

Join us as we embark on this breakthrough and become inspired to deliver.

The Senior Director of Quality Assurance is responsible for development and maintenance of quality business strategy and quality management system compliant with FDA drugs, biologics and combination products, with awareness of ISO 13485. 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 Senior Director will direct the development, implementation and maintenance of quality assurance systems and activities. He or she will provide the signatory authorization from Quality for control documentation and final product disposition. The Senior Director will be responsible for the investigations and resolution of product quality and compliance issues seen at approved service providers. He or she 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 and supports the company’s research and development programs. The position will report to Aerogen Pharma CEO.

• Develop and implement end-to-end quality assurance policies, procedures, and guidelines that comply with global regulatory standards (e.g. FDA, EMA, ICH).
• Focus on the 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 investigation 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 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 company 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.

• Experience with Quality Management Systems implementation and maintenance.
• A minimum of a bachelor's degree in a scientific discipline is required.
• A minimum of 10 years’ experience in the biopharmaceutical industry is required.
• A minimum of 10 years working…