GCLP QA Specialist IV - VICD

Program Description

The Vaccine, Immunity and Cancer Directorate (VICD) has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines and other cancer preventive strategies in the context of preclinical and clinical studies. As part of a large effort, the National Institute of Allergy and Infectious Diseases (NIAID) and the Frederick National Laboratory (FNL) are developing vaccines with durable protection for seasonal influenza virus.

VICD is leading the development of immunoassays with the highest reproducibility, sensitivity, and specificity for evaluating immune responses against the virus and vaccine.

• Quality Leadership, Strategy & Innovation
  • Provide senior-level leadership in development, implementation, and continuous improvement of GCLP‑compliant quality systems across all laboratory operations within the directorate.
  • Ensure the highest standards of scientific rigor, data integrity, and regulatory compliance across all laboratory activities.
  • Drive adoption of innovative quality assurance practices and employ modern quality system tools to enhance efficiency, streamline workflows, and reduce operational burden.
  • Identify and implement novel approaches to quality oversight, including risk‑based QA, real‑time monitoring strategies, and digital quality solutions.
  • Serve as a strategic advisor to laboratory and program leadership, aligning quality practices with scientific and operational priorities.
  • Champion an inspection‑ready culture and embed quality as an enabler of scientific excellence rather than a checkpoint function.
• Real‑Time QA Oversight & Laboratory Engagement
  • Maintain a strong, visible physical presence in the laboratory, providing real‑time QA oversight across laboratory activities.
  • Embed quality into daily laboratory operations by proactively working with lab managers and personnel to monitor and identify risks, gaps, and opportunities for improvement.
  • Partner closely with laboratory managers, investigators, and scientists to ensure quality is integrated into experimental design and execution.
  • Foster a collegial, transparent, and solutions‑oriented environment that supports both compliance and scientific productivity.
• Immunology Assays & Scientific Quality Oversight
  • Provide QA oversight for cellular immunity (Flow cytometry) and serological assays (e.g., ELISA, Luminex), including those supporting clinical testing under CLIA.
  • Support and review in‑house assay development, standardization, qualification, and validation processes.
  • Ensure appropriate controls, documentation, and reproducibility of assays used in clinical sample testing.
  • Collaborate with scientists to ensure assay performance meets both regulatory expectations and scientific objectives.
• LIMS, Digital Systems & Data Integrity
  • Provide oversight of Laboratory Information Management Systems (LIMS).
  • Ensure data integrity, traceability, and compliance across computerized systems and digital workflows.
  • Support validation, implementation, and continuous improvement of computerized systems and electronic quality tools.
  • Promote the use of digital solutions to enhance audit readiness, data visibility, and operational efficiency.
  • Auditing, Inspection Readiness & CAPA Oversight
    • Lead and conduct complex internal audits and oversee external audits with a focus on continuous inspection readiness.
    • Direct investigations of deviations, non‑conformances, and out‑of‑specification results, ensuring robust root cause analysis.
    • Oversee development, implementation, and effectiveness of Corrective and Preventive Actions (CAPAs), in collaboration with managers, with a focus on sustainable solutions.
    • Drive robust root cause analysis and risk‑based CAPA programs to address findings and prevent recurrence.
• Quality Systems & Documentation
  • Develop, review, and approve SOPs, policies, and quality documentation.
  • Ensure robust document control systems and compliance with GCLP or CLIA expectations.
  • Drive harmonization and standardization of laboratory processes across programs where appropriate.
• Training, Mentorship & Culture of Quality
  • Provide continuous mentorship…