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Senior Manager, QA Laboratory Compliance

4 months ago

Gaithersburg, United States Novavax Full time

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

Weare seeking aSr. Manager, Quality Assurancetojoin our Laboratory Compliance organizationinGaithersburg,MD.The candidate will be responsible for leading a team in providing quality oversight in support of batch related, stability operations, health agency responses and technology transfer testing and ensuring compliance in Novavax's GxP laboratories in the U.S. The candidate will also be responsible for providing quality oversight of testing performed by contract testing laboratories. This position reports directly to the Director, Laboratory Compliance.


Essential Functions

  • Strong leadership and managerial skills, with the ability to effectively mentor and develop team members.

  • Strong experience with QMS related to robust investigations of nonconformances, out of specification test results and change controls.

  • Monitor the metrics for laboratory compliance team and QA initiatives and performance improvements.

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

  • Proven experience leading successful regulatory inspections and audits.

  • Provide Quality oversight for various regulatory submission deliverables and Health authority responses.

  • Partners with Quality Control and Analytical Development functions at Novavax in support of method qualifications, method validations/verifications, method transfer, specifications, batch release, and stability program activities.

  • Ability to manage multiple projects simultaneously and prioritize effectively in a fast-paced environment.

Required Knowledge, Skills, and Abilities

  • The ability to effectively build and maintain relationships across the organization to effectively solve problems.

  • The ability to influence, enable, and drive change as applicable with both internal and external customers.

  • The ability to produce high-quality work on complex problems with cross-functional and global impact; to take ownership of quality considerations and standards across the team's work product.

  • Excellent communication, interpersonal and problem-solving skills.

  • Certification in quality management or regulatory affairs (e.g. ASQ, RAPS) is a plus.

  • Manage and mentor QA team members, fostering a culture of continuous improvement and accountability.

Education, Experience, Licenses & Certifications

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

  • 8+ years' experience in GMP biologics and/or vaccine, pharmaceutical manufacturing

  • 5+ years of leadership experience in Quality Assurance.

  • Extensive knowledge of U.S., EU, and ICH regulations and guidance's related to GxP activities, with particular focus on the Laboratory Operations.

This position may require periodic weekend/evening work.

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.