GCLP QA Specialist IV - VICD

Overview Job ID: req4534 Employee Type: exempt full-time Division: Vaccine, Immunity and Cancer Directorate Facility: Frederick: ATRF Location: 8560 Progress Dr, Frederick, MD 21701 USA 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. 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. VICD is leading the development of immunoassays with high reproducibility, sensitivity, and specificity for evaluation of immune responses against the virus and vaccine. VICD is seeking a highly experienced Quality Assurance Specialist IV to provide senior-level oversight of Good Clinical Laboratory Practice (GCLP) and CLIA compliant operations. This role ensures the highest standards of scientific rigor, data integrity, and regulatory compliance across laboratory programs supporting clinical research and vaccine studies. This position requires 100% onsite work. Key Roles/Responsibilities Quality Leadership, Strategy & Innovation Provide senior-level leadership in the development, implementation, and continuous improvement of GCLP-compliant quality systems in all laboratory operations within the directorate. 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 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 and guidance to laboratory personnel and QA staff in GCLP, CLIA and modern quality practices. 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 Basic Qualifications Bachelor’s degree from an accredited college/university or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency. Minimum of eight (8) years of progressively responsible experience. Strong knowledge and experience of GCLP, CLIA regulations and laboratory quality requirements for clinical trial testing. Understanding of immunology, particularly antibody and serological assays. Demonstrated experience supporting assay development, standardization, qualification, and validation. Experience with LIMS and computerized systems (e.g., LabVantage) and data integrity principles. Proven experience implementing or supporting innovative QA practices and process improvements. Demonstrated ability to work in close partnership with scientific leadership and laboratory teams. Strong critical thinking skills and commitment to scientific rigor and compliance. Excellent interpersonal and communication skills, with the ability to influence and build trust. Ability to obtain and maintain a security clearance. Preferred Qualifications Preferred Qualifications Master’s degree or PhD. Experience supporting clinical trial laboratories, particularly in vaccine or infectious disease research. Familiarity with electronic quality management systems and digital QA tools. Certification in quality (e.g., ASQ Certified Quality Auditor or equivalent). Experience in high-throughput or complex laboratory environments. Key Competencies Strategic and systems-level thinking. Innovation in quality systems and process improvement. Strong partnership and relationship-building skills. Visible, engaged leadership within laboratory environments. Commitment to rigor, efficiency, and continuous improvement. Commitment to mission-driven, science-enabled quality practices. Why Join Us Mission-Driven Impact: Support critical clinical research and vaccine development programs. Scientific Excellence: Collaborate with leading immunologists in a premier NIH environment. Innovative Role: Shape and modernize quality systems using forward-thinking approaches. Collaborative Culture: Work in a mission oriented collegial, partnership-driven environment. Job Hazards This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations. Commitment to Non-Discrimination All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws. Pay And Benefits Pay and benefits are fundamental to any career decision. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here. Salary range: 92,900.00 - 133,215.00 USD. The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part-time positions. #J-18808-Ljbffr