Director, Clinical Quality Assurance

If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place.

Individually, we're skilled, driven, and confident risk-takers.Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you!

Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world's most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide.

Job Summary

We are seeking a Director, Quality Assurance, to join our Clinical Quality Assurance (CQA) organization. The person will provide leadership for the team responsible for providing quality oversight in collaborating with required functional areas in ensuring compliance with applicable Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), and Good Pharmacovigilance Practices (GVP) regulations. This position reports directly to the Vice President, Global Quality Systems and Compliance.

Essential Functions

• Ensure the implementation and/or maintenance of global, phase-appropriate clinical Quality Management System (QMS) policies and procedures to ensure compliance to applicable regulations, including U.S. and EU.

• Provide quality oversight of Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), and Good Clinical Laboratory Practices (GCLP) activities to ensure patient safety and data integrity.

• Lead GCP, GPV, and GCLP inspection readiness activities in collaboration with internal stakeholders, in preparation for regulatory and third-party inspections related to Novavax sponsored clinical and pharmacovigilance activities.

• Plan, coordinate, and execute/oversee the management of Investigator Site Audits to ensure adequate GCP risk mitigation in collaboration with internal and external stakeholders.

• Oversee complex quality investigations of Quality Issues, Quality Events, Deviations, Protocol Deviations, GCP Breaches, Reportable Non-Compliance, Fraud and Scientific Misconduct and resultant For Cause Audits

• Ensure the effective management of resources and provide the appropriate level of oversight to progress work to meet organizational timelines.

• Serve as internal Novavax subject matter expert for changes in GCP, GPV, and GCLP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (e.g. ICH), and best industry practices

• Participate in the development and execution of strategic plans for CQA, which includes driving the identification and implementation of improvement opportunities.

• Develop and administer plans and performance requirements linked to the Clinical Quality Assurance department.

• Hire, develop, and retain clinical QA personnel to create a high-performing credible team.

Required Knowledge, Skills, and Abilities

• Skills in developing and maintaining collaborative internal and external relationships.

• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.

• The ability to enable and drive change while being focused on internal and external customers.

• Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax.

• The capability to manage multiple projects and responsibilities concurrently and maintain adherence to timelines.

• The ability to model, lead, train, motivate and develop employees to be exceptional performers and collaborators.

Education, Experience, Licenses & Certifications

• Bachelor's Degree in a scientific discipline; advanced degree in related field is preferred.

• 12+ years' experience in pharmaceutical, biologics and/or vaccine manufacturing.

• 10+ years leadership experience in Quality.

• Direct experience in managing Health Authority inspections as well as Clinical Investigator Site audits.

• Knowledge and expertise in GCP, GCLP, and GPV regulations and guidance applicable to global pharma, biologics, or combo products.

• Excellent multi-tasking, analytical, organizational and leadership skills.

• Ability to troubleshoot, identify root cause and systematically resolve problems.

• Ability to communicate clearly and effectively with all levels of the organization.

• Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.