Manager, Quality Assurance (CMC)

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 individual in this role is responsible for overseeing quality and regulatory compliance for CMC and maintaining oversight of contracted development, manufacturing and distribution organizations, including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) across drug, device and combination operations.

The primary responsibility of this role is to identify and reduce regulatory and compliance risk through continuous monitoring and evaluating Aerogen Pharma and supplier policies, procedures and practices. This includes the management of quality dispositions, managing/ leading audits, addressing quality issues and facilitating investigations to ensure compliance is built into the operational systems. Quality Assurance staff communicate and work effectively with leadership to take necessary actions to mitigate identified risks.

Quality Assurance staff are accountable for the effective implementation of the Quality Management System (QMS) and serve as the subject matter expert on policies, processes and procedures of the QMS by developing a broad knowledge of the practice, business and technology as it relates to product manufacturing.

• What are the key responsibilities?
• Develop CMC expertise related to manufacturing and ensure change management activities are in place to support reporting requirements for regulatory filings within a combination product setting.
• Ensuring products used in clinical trials are following the information and documentation provided to Health Authorities.
• Identifying potential quality gaps and contributing to strengthening contract organizations production facilities’ compliance level and relationship management.
• Support the continuous improvement of the quality system including contract organization qualification, contract organization lifecycle management, through regular communication and collaboration, audits (including internal audits) and other quality oversight actions.
• Lead Auditor to conduct qualification and recurrent domestic and international contract organization audits. Independently managing audits of documents, databases, and internal systems in compliance with drug/ device and combination regulations and Aerogen Pharma policies and procedures; assess impact of audit findings on safety, data integrity, and business operations.
• Perform review of product manufacturing documents for clarity and compliance with regulatory requirements, and product disposition.
• Responsible for QA oversight of CMC outsourced activities ensuring product manufacturing service risks are escalated to management.
• Coordinate QA reviews and submissions for GMP manufacturing.
• QA oversight of CMC out-sourced activities and participation in method transfer and tech transfer activities.
• Be an ambassador in improving the Company quality culture, and promote quality awareness through training, mentoring, and participation in teams and task forces.
• Analyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation.
• Lead investigations into significant quality issues, scientific misconduct and serious breach; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution.
• Other duties as assigned.

What education and experience are required?

• A bachelor’s degree in a (Bio)Chemistry or similar is required and a minimum of 7 to 10 years’ experience in a manufacturing quality control/ quality assurance role.
• Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing is required. Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
• Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice.
• Demonstrated ability in using continuous improvement techniques to contribute to a pharmaceutical QMS (e.g., Root Cause Analysis, etc.).
• Experience with eDocument Management, Training, CAPA’s, Audit systems and tools.
• CMC QA experience within method transfer and technology transfer activities.
• Audit experience (conduct or delegate) is mandatory.
• Ability to work independently with limited direction, within prescribed guidelines, or as a team member
• Ability to work well in a deadline-driven environment.
• Ability to travel (approx. 20%).

What key skills will make you great at the role?

• Exceptional human relations and communication (written, verbal, and listening) skills are required. Should be very detail-oriented and can work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
• Strong analytic skills coupled with critical thinking skills are essential in this role. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
• Expertise in SharePoint configuration/ Power BI tools highly advantageous.

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.

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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.