Aerogen Pharma - Senior Director of Quality
Apply NowCompany: Aerogen
Location: Des Moines, IA 50380
Description:
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 QA 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.
Reporting into the SVP of Regulatory Affairs and Quality Assurance Officer, you will establish cross-functional roles and responsibilities and have accountability for execution of all strategic imperatives. The Senior Director of Quality will direct the development, implementation and maintenance of quality assurance systems and activities. You will be the primary quality representative and primary contact with external partners and suppliers.
Duties and 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.
Review and approve documentation related to manufacturing, analytical testing, labeling, and other quality related activities.
Provide signatory authorization from Quality for control documentation and final product disposition
Responsible for the investigations and resolution of product quality and compliance issues seen at approved service providers.
Oversee clinical quality assurance (GCP).
Provide input and oversight of quality investigation performed internally and at all third parties for drug, biologics and medical devices.
Perform end-to-end risk assessments to identify potential quality issues and implement effective mitigation strategies.
Conduct 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.
Education and Experience 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
Experience with electronic documentation systems is a plus.
Laboratory QC experience is a plus.
Why Aerogen Pharma
As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralise our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.
We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognised and professional development is encouraged.
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 QA 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.
Reporting into the SVP of Regulatory Affairs and Quality Assurance Officer, you will establish cross-functional roles and responsibilities and have accountability for execution of all strategic imperatives. The Senior Director of Quality will direct the development, implementation and maintenance of quality assurance systems and activities. You will be the primary quality representative and primary contact with external partners and suppliers.
Duties and 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.
Review and approve documentation related to manufacturing, analytical testing, labeling, and other quality related activities.
Provide signatory authorization from Quality for control documentation and final product disposition
Responsible for the investigations and resolution of product quality and compliance issues seen at approved service providers.
Oversee clinical quality assurance (GCP).
Provide input and oversight of quality investigation performed internally and at all third parties for drug, biologics and medical devices.
Perform end-to-end risk assessments to identify potential quality issues and implement effective mitigation strategies.
Conduct 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.
Education and Experience 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
Experience with electronic documentation systems is a plus.
Laboratory QC experience is a plus.
Why Aerogen Pharma
As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralise our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.
We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognised and professional development is encouraged.