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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.
What is the role?
The Senior Director of Quality Assurance is responsible for development and maintaining 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. Sr Director of Quality will direct the development, implementation and maintenance of quality assurance systems and activities. Will provide the signatory authorization from Quality for control documentation and final product disposition. Will be responsible for the investigations and resolution of product quality and compliance issues seen at approved service providers. Will have oversight of clinical quality assurance (GCP). This position is a hybrid role, located in Morrisville, NC office and is a key member of the leadership team that contributes and supports the company's research and development programs. This position will report 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).
• 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 sponsors' 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'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 is required.
• A minimum of 10 years' experience in the biopharmaceutical industry is required
• A minimum of 10 years working in a Quality Assurance with a thorough understanding of cGMP is required
• Direct experience with health authority inspections required
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 to #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. There's something for everyone! 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.
Visit our careers website for more information about life at Aerogen.
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 [email protected]. Please provide your name and preferred contact method.