Quality Assurance Specialist IV, Compliance

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 Quality Assurance Compliance Specialist IV to join our Quality department. The Specialist IV will be primarily responsible for managing product development and testing related activities working closely with Analytical development, Quality Control, QA Ops, QA / QC Technical Support and manufacturing organizations This position may be expected to manage a small team to ensure approval of, including but not limited to, study reports, reference standard qualifications protocols and reports, deviations, out of specification (OOS) investigations, CAPAs and change controls to meet business goals in a timely and compliant manner.

This position reports directly to the Director of Laboratory Compliance in the GSQC organization

Essential Functions

• Provide Quality technical support to the internal Novavax QC organization as well as cross-functional Novavax teams working through analytical data reviews for product development, batch release and / or GMP testing activities both internally and at our contract manufacturing and testing sites.
• Support Novavax technical teams by providing QA input, review, and approval to study designs, protocols, technical reports, and new program implementations.
• Support Quality Control during regulatory inspections and in maintenance of a state of inspection readiness
• Support the quality impact assessments / risk assessments for deviations, OOS investigations, and change controls related to testing activities and provide the required Quality assessment and approval for these quality records.
• Maintain working knowledge of Novavax Documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
• Stays current and is an internal Novavax subject matter expert for changes in GxP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.

e. : ICH, PTC, ISPE, etc.), and best industry practices.

• Effectively collaborates with departments across the company to analyze and resolve technical issues in accordance with appropriate quality standards.
• Serves as Quality representative on new product introduction teams.
• Provides oversight and guidance to junior level specialists

Required Knowledge, Skills, and Abilities

• Bachelor's degree in engineering, biology, Chemistry, or related field with 10+ years' experience in the Pharmaceutical / Biotech / Device industry or equivalent experience / education
• Demonstrated knowledge of regulatory requirements for medical device or combo products
• Understanding of Quality Assurance systems
• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
• Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax.
• Capable of managing multiple priorities, adaptability, agility to maintain adherence to timelines.

Education, Experience, Licenses & Certifications

• Demonstrated advanced technical knowledge to trouble shoot and provide solutions.
• Demonstrated ability to lead and develop more junior employees.
• Demonstrated ability to manage process improvement projects.
• Demonstrated knowledge of GMP, GLP, GCP and GCLP expectations
• The ability to keep colleagues and management apprised of projects and status independently and appropriately; to anticipate future needs based on prior experiences.
• The accountability to reach established goals or targets for moderately complex tasks with the involvement of immediate teammates without compromising commitments
• The capability to assist other team members in a small number of areas and learns additional knowledge cooperatively; to build influence by completing tasks and presenting new ideas;

to contribute to cross-functional work; to build relationships internally and coordinates work with others

Novavax offers a base salary, annual bonus, equity grants, professional career development / growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer / Veterans / Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.