Senior 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 Sr. Director, Clinical Quality Assurance to join our Clinical Quality Assurance department in Gaithersburg, MD. The incumbent will provide leadership and collaborate with required functional areas to ensure compliance with applicable Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) and Good Clinical Laboratory Practices (GCLP) regulations as well as any additional applicable regulatory requirements. The incumbent is expected to build and maintain cross-functional relationships with key functional areas including but not limited to: Clinical Operations, Pharmacovigilance, and Regulatory Affairs.

This position reports to the Vice President, Global Quality Systems and Compliance.

Essential Functions

Responsibilitiesinclude but are notlimitedto:

• Serve as the strategic leader and operational manager to direct, oversee, and manage all clinical quality assurance activities.

• Drive the design, analysis, and oversight of global, phase-appropriate clinical Quality Management System (QMS) policies and procedures to ensure compliance to applicable regulations, including U.S. and EU.

• Direct, oversee, and manage the quality oversight of GCP, GVP and GCLP activities (including SOP/policy development and maintenance, vendor management, internal and external audit functions, and clinical batch release program) to ensure patient safety and data integrity.

• Provide leadership, direction, and mentorship across all levels of the organization to assure quality assurance strategies are known and implemented.

• Keep senior leadership apprised of changes to the clinical quality compliance landscape affecting business performance.

• Develop and administer budgets, 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.

• Serve as the primary contact in QA for the oversight of Clinical Studies in US, EU, and ROW to ensure compliance with all GCPs from manufacturing, labeling, distribution, and site qualification to ensure compliance with all regulatory requirements in the country the study is conducted.

• Liaise with the Head of Clinical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and Information Technology as needed for the clinical studies.

• Establish/ensure/remediate as needed the current quality processes, systems and procedures associated with clinical studies.

• Collaborate with cross-functional management to drive clinical process improvements and alignments.

• Serve as the primary contact for all regulatory or third-party inspections related to Novavax sponsored clinical and pharmacovigilance activities. This includes on site at Novavax and remote sites.

• Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GCP and GVP QA activities.

Required Knowledge, Skills, and Abilities

• Knowledge of global regulatory expectations (including FDA and EMA).

• Experience with senior level interactions and demonstrated collaboration with Clinical, Regulatory, Pharmacovigilance and Medical Affairs functions.

• Excellent communication and organizational skills.

• Demonstrated knowledge of GCP, GCLP and GVP regulations for pre-clinical and clinical stage work.

• Direct experience in successfully managing Health Authority Inspections and multiple projects and responsibilities concurrently.

• Experienced and fully capable to implement and ensure quality in a GCP-regulated environment (eg, GCP oversight, auditing, electronic systems management, laboratory management, PAI inspection readiness)

• Skilled in developing collaborative internal and external relationships.

• Team player willing to roll up her/his sleeves as the situation requires to get the right result; ability to combine hands-on attention to detail with the ability to step back and think strategically.

• Ability to make rationale, scientific, timely, and compliant risk-based decisions.

• Excellent verbal and written communication skills

• Ability to build and manage a high performing group; attract, retain, and coach best talent. Develop direct reports in their career paths, particularly ensuring that a successor is evolved.

• Ability to think creatively, take a broad systemic view while maintaining a meticulous eye for detail round out the description of the intellectual skills required for this position.

Education, Experience, Licenses & Certifications

• Bachelor's degree in a scientific discipline; Master's degree or higher preferred

• 15+ years of experience in GMP pharmaceutical, biologics and/or vaccine manufacturing

• 10+ years of leadership experience in GCP/GVP QA.