Associate Director, Quality Assurance (Clinical)

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 clinical quality assurance activities for clinical development programs. This includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and Good Pharmacovigilance Practice (GVP).

The primary responsibility of this role is to identify and reduce regulatory and compliance risks through continuous monitoring and evaluation of Aerogen Pharma and supplier policies, procedures, and practices. This includes managing/ leading audits, addressing complaints and quality issues, and facilitating investigations to ensure compliance is integrated into operational systems. Quality assurance staff effectively communicate and collaborate with leadership to take necessary actions to address identified risks.

Quality assurance staff are accountable for the effective implementation of the Quality Management System (OMS) and serve as subject matter experts on policies, procedures, and practices of the QMS. They develop a broad knowledge of the practice, business, and technology relevant to product manufacturing.

What are the key responsibilities?

• Provide professional expertise and guidance on regulations to clinical development teams to proactively identify compliance issues/ risks and recommend mitigations.
• Liaise with various functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.
• Independently manage domestic and international audits of sites, documents, databases, contract organizations or internal systems in compliance with GCP and Aerogen Pharma policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations.
• 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; working with regulatory to ensure reporting of potential or confirmed violations to regulatory authorities.
• Lead and support GCP/GLP/GPV health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Aerogen Pharma.
• 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.
• 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?

• BA/BS degree, preferably in biological sciences, or similar field, requiring a minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
• Minimum 5 years of GCP-related Quality Assurance or relevant clinical trial and medical device experience.
• Extensive knowledge and/or awareness of ICH GCP, GLP and GVP and applicable global regulations and guidance for clinical development. Additional experience with other requirements (Good Manufacturing Practice, 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.
• Audit experience (conduct or delegate) is mandatory.
• Ability to work independently with minimal direction.
• 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 have the ability to 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.

​

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.