Associate Director, QA (Clinical)

Aerogen Pharma; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

A clinical-stage specialty pharmaceutical company is seeking an Associate Director, QA. This role involves overseeing quality compliance for clinical development programs and managing audits. The ideal candidate has at least 10 years of industry experience and expertise in GCP/GLP regulations. Join us to contribute to transformative neonatal care solutions.

Qualifications

• Minimum of 10 years of experience in the pharmaceutical or biotechnology field.
• Minimum of 5 years of GCP-related Quality Assurance experience.
• Extensive knowledge of ICH GCP, GLP, and GVP regulations.

Responsibilities

• Oversee quality and regulatory compliance for clinical development programs.
• Liaise with external parties to promote quality consistency.
• Independently manage domestic and international audits.
• Lead investigations into quality issues and misconduct.
• Promote quality awareness through training and mentoring.

Skills

Human relations and communication skills

Analytic skills

Critical thinking skills

SharePoint configuration

Power BI tools

Education

BA/BS degree in biological sciences or similar

Job description

Join to apply for the Associate Director, QA (Clinical) role at 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.

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).

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.
• 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.
• Lead investigations into significant quality issues, scientific misconduct and serious breach.
• Lead and support GCP/GLP/GPV health authority inspections.
• 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.
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution.

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.
• 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.

What key skills will make you great at the role?

• Exceptional human relations and communication skills are required.
• Strong analytic skills coupled with critical thinking skills are essential in this role.
• 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.

We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.