Associate Director, GCLP Quality Assurance (Temp to Perm)


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Gaithersburg, MD

Job Description

As posted by the hiring company

Job Overview:

**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.**

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases.  We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform.  Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

The Associate Director, GCLP QA is responsible for internal and external QA Activities to support NVX GCLP program for Clinical Immunology and serological assessment of immunogenicity for compliance to Novavax SOPs and all relevant regulations, guidelines, and industrial best practices.  This role will start on a temporary basis with the ability to convert permanent. 

Core Functions:

  • Application of RQA/WHO GCLP Quality Principles in a GCP driven environment in NVX Clinical Immunology (CI) and Serology Laboratories and differentiate and define GCLP regulatory and industry standards, and to describe the three categories of laboratory practices (GCP, GCLP, GLP) as they relate to assay analysis in clinical research.
  • Perform routine QA duties to ensure GCLP compliance plus other regulatory requirements relating to oversight of CI laboratory activities for COVID19, Influenza, RSV and other immunological assays.
  • Develops, implements, and maintains policies, systems, procedures, and tools for CQA audit management of quality and sustained compliance with GLP/ GCLP standards.
  • Develop, implement, and execute GLP and GCLP audit strategy and plan using risk-based approach and integrate that with the Global Audit Master Schedule for all audit types.
  • Manage new vendor qualifications and existing vendor re-qualification for the CI Lab with CQA-QMO group.
  • Monitor and manage findings, deviations/Quality Events and CAPAs timeliness and effectiveness checks.
  • Identify and follow-up on any unresolved audit findings identified in a CQA Audit.
  • Support GLP/GCLP Regulatory health authority inspections activities and the development of corrective actions for findings from such inspections; prior experience preferred.
  • Develops and mentors direct reports for leadership opportunities.
  • Identifies continuous improvement opportunities, new technologies, and innovations and implement processes and system that increase efficiency and compliance.
  • Assist CI Lab Management on development of Quality Systems and SOPs for GCLP purposes and train laboratory staff on the same and new GCLP regulations and/or updates.
  • Participate in the selection of contract GCLP laboratories and associated vendors.
  • Lead GCLP laboratories QA qualification audits, observations, development of appropriate corrective and preventive actions, and observation closure follow up.
  • Participate in review and approval of bioanalytical methods transfer and internal method validation in Clinical Immunology.
  • Conduct contract laboratories monitoring; participate in out of trend and protocol deviations investigations.
  • Identify QA and compliance issues at external and internal testing laboratories; implement solutions to ensure timelines are maintained.
  • The candidate must be able to solve problems, communicate effectively, and trouble-shoot creatively within GCLP guidelines.

Core Skills:

  • WHO Good Clinical Practice (GCLP) ISBN 978 92 4 159785 2  World Health Organization 2009                      
  • Proficiency of the GLPs—US 21 CFR 58 regulation and International Organization for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice.
  • Expertise in Bioanalytical Laboratory Practice—United States Food and Drug Administration (FDA), FDA Guidance for Industry Bioanalytical Method Validation and European Medicines Agency (EMA) Draft Guideline on Validation of Bioanalytical Methods.
  • Experience in bioanalytical methods development, validation, and laboratory investigations.
  • Understanding laboratory techniques related to immunological assays such as ELISA, Serum Sample Incubation and Human Antibody detection are preferred.

Requirement and Experience:

  • Bachelor’s Degree in Biological sciences, Analytical Chemistry, or related fields or equivalent combination of education and experience
  • 10+ years of relevant pharmaceutical, auditing and QA experience in GLP/GCLP regulated roles in sponsor companies.
  • SQA, CQA or other quality related certification.
  • Prior experience working at a CRO/third-party laboratory service provider.
  • Understanding of regulatory trends, regulations and guidelines such as CAP, CLIA, 21 CFR Part 58, ISO 9001:2015, ICH E6 R2/3, 21 CFR Part 11, WHO GCLP required.
  • Ability to evaluate and apply compliance requirements/guidelines to applicable situations.
  • Experience leading teams and handling project management activities without supervision
  • Excellent time management skills.
  • Strong communication skills and technical writing ability
  • Knowledge of regulatory procedures in US, EU, and Asian markets.
  • Understanding of contract management/legal aspects for Quality agreements and CDAs.
  • Travel required - 30% (Domestic and International).
  • Local candidates only within commutable distance from the Novavax Gaithersburg office.

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.