Contract (12 months + with possibility to convert to FTE)
Location:
hybrid, 3x per week in the office, ~8x per year traveling to do audits (domestic and international)
Position Overview:
The GCLP QA Lead is responsible for internal and external QA Activities to support GCLP program for Clinical Immunology and serological assessment of immunogenicity for compliance to SOPs and all relevant regulations, guidelines, and industrial best practices.
Responsibilities include, but not limited to:
- 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, 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 GCLP standards.
- Develop, implement, and execute 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.
- Support GCLP Regulatory health authority inspections
- Lead, monitor and manage unplanned deviation investigations from audit findings/ Quality Events /Gap Analysis/Inspections by conducting root cause analysis, risk assessment, and CAPA with scientist, or SME within specified timeline and effectiveness checks.
- Identify and follow-up on any unresolved audit findings identified in a CQA Audit.
- 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.
- 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.
- Preferred - WHO Good Clinical Laboratory 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 IgG, ACE, ELISA, Serum Sample Incubation and Human Antibody detection are preferred.
Minimum Requirements:
- Bachelor's Degree in Biological sciences, Analytical Chemistry, or related fields or equivalent combination of education and experience
- 7+ years of relevant pharmaceutical, auditing and QA experience in preferably in GCLP; but GLP experience in laboratory setting would be in consideration too.
- Experience with Non/Clinical sample analysis under GLP/GCLP
- 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%
- Local candidates only within commutable distance from the Gaithersburg office.