Quality Assurance Manager II - VICD

Quality Assurance Manager II - VICD

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

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 of recent and part of a large effort, the National Institute of Allergy and Infectious Diseases (NIAID) and the Frederick National Laboratory (FNL) and other stakeholders 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 evaluation of immune responses against the virus and vaccine.

VICD is seeking a highly experienced Quality Assurance Manager II to lead, maintain, and continuously improve the VICD quality management program with oversight of Good Clinical Laboratory Practice (GCLP)- and
-CLIA compliant operations. This role is integral to ensuring the highest standards of scientific rigor, data integrity, and regulatory compliance across laboratory programs supporting clinical research and vaccine studies. This position requires an active and visible presence within the laboratory, providing real-time quality assurance oversight and working in close partnership with scientific leadership and bench scientists on a daily basis. The incumbent will align quality systems with routine and complex immunological workflows, including assay development and validation and clinical testing, while advancing innovative, efficient, and forward-looking quality practices, in a high-performing laboratory organization.

The incumbent will possess management experience in a laboratory environment, with strong quality systems expertise, and effective leadership and influence across multiple teams and functions. This position requires 100% onsite work.

VICD is a fast-paced laboratory organization driven by science and technology advancement to support serology and other immunological assay development and implementation on a global scale. As Quality Assurance Manager II, the incumbent is responsible for the oversight and advancement of quality systems across the VICD organization. The incumbent is expected to report to the work site daily. There is no hybrid or remote option for this position.

Quality Leadership, Strategy & Innovation:

• Lead, administer, maintain, and improve quality management program across all laboratory operations.
• Partner with VICD leadership and laboratory managers to ensure efficient quality systems that support the development, implementation, and continuous improvement of GCLP-compliant operations across diverse laboratories.
• Ensure the highest standards of scientific rigor, data integrity, and regulatory compliance across all laboratory activities.
• Drive the adoption of innovative quality assurance practices and employ modern quality system tools and practices 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…