Quality Management Specialist

About the role

Provide services as a Quality Management Specialist in support of the overall functions of the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).

Responsibilities

• Serve as a Quality Management Specialist providing independent quality oversight for the implementation, validation, maintenance, and retirement of GxP regulated computerized systems.
• Apply thorough knowledge of GxP regulations, including Computer Software Assurance (CSA) and Computer System Validation (CSV), to guide teams in meeting compliance expectations.
• Recommend and collaborate on solution approaches, working both autonomously and with cross functional stakeholders to ensure systems meet regulatory and quality standards.