GCLP QA Specialist IV - VICD

About the role

The Frederick National Laboratory 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 is integral to ensuring the highest standards of scientific rigor, data integrity, and regulatory compliance across laboratory programs supporting clinical research and vaccine studies.

Responsibilities

• 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.
• Embed quality into daily laboratory operations by proactively working with lab managers and personnel to monitor and identify risks, gaps, and opportunities for improvement.
• 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.
• 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.
• Develop, review, and approve SOPs, policies, and quality documentation.
• Ensure robust document control systems and compliance with GCLP or CLIA expectations.
• Lead training initiatives that promote GCLP compliance.
• Champion a collaborative culture of quality excellence that emphasizes rigor, innovation, collegiality, and shared accountability.

Qualifications

• Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• A 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.

Benefits

The Frederick National Laboratory offers a comprehensive benefits package including competitive compensation, Health and Wellness programs, Income Protection, Paid Leave, and Retirement. For more details, please refer to the company's website.

Pay and Benefits

The posted pay range for this job is $92,900.00 - $133,215.00 USD. Additional factors such as responsibilities of the job, education, experience, knowledge, skills, and abilities, and internal equity, and alignment with market data are considered in extending an offer.

Equal Opportunity Employer

We are committed to creating a diverse environment and encourage applications from all qualified individuals. We are proud to be an equal opportunity employer and do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status.