Quality Assurance Manager II - VICD
About the role
The Vaccine, Immunity and Cancer Directorate (VICD) at the Frederick National Laboratory seeks a highly experienced Quality Assurance Manager II to lead, maintain, and continuously improve the quality management program with oversight of Good Clinical Laboratory Practice (GCLP)- and CLIA-compliant operations.
Responsibilities
Lead, maintain, and continuously improve the VICD quality management program with oversight of GCLP- and CLIA-compliant operations.
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.
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.
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.
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.
Lead and conduct complex internal audits, quality observation activities, and oversee external audits with a focus on continuous inspection readiness.
Direct and improve processes for 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.
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.
Provide continuous mentorship and guidance to laboratory personnel and QA staff in GCLP, CLIA, and modern quality practices.
Foster a culture of quality, compliance, and accountability.
Lead training initiatives that promote GCLP compliance.
Lead training programs to ensure staff competency in clinical testing requirements, data integrity, and inspection readiness.
Champion a collaborative culture of quality excellence that emphasizes rigor, innovation, collegiality, and shared accountability.
Qualifications
Possession of a Master’s degree in Immunology, Virology, Biology or other Science related major from an accredited college/university according to the Council for Higher Education Accreditation (CHEA).
Minimum of 10 years of related experience including six (6) years quality assurance experience in laboratory operations within a GCLP, GLP or GMP environment and a minimum of four (4) years in leadership/managerial capacity experience overseeing staff in a laboratory environment.
Strong knowledge and experience of GCLP, CLIA regulations and laboratory quality requirements for clinical trial testing.
Demonstrated experience supporting assay development, standardization, qualification, and validation.
Experience in internal audits, readiness assessments, quality observations, and follow-up of remediation activities.
Experience with LIMS and computerized systems (e.g., LabVantage) and data integrity principles, electronic laboratory notebooks (ELN), or other electronic systems used to support laboratory operations and quality oversight.
Experience with software validation for immunological testing.
Proven experience implementing or supporting innovative QA practices and process improvements across multiple functional groups performing diverse laboratory and operational work.
Computer literacy and proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook with demonstrated skills in graphing and presentation materials including tracking, reporting, and document management.
Ability to analyze information, organize records, identify trends, and present findings clearly and accurately.
Excellent interpersonal and communication skills, with the ability to influence and build trust.
Ability to obtain and maintain a security clearance.