Senior Quality Affairs SME | Healthcare and Life Sciences [HHS120025]
Core
Senior Quality Affairs SME providing subject matter expertise in quality assurance and control regulations for medical countermeasures (vaccines, therapeutics, diagnostics) supporting BARDA's R&D mission.
Role type
Senior IC Quality Affairs SME (Healthcare and Life Sciences)
Builds
Medical countermeasures development pathways, regulatory compliance strategies, and quality management frameworks for federal programs.
Domain
Healthcare and Life Sciences / Biopharmaceuticals / Government Contracting
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GXP compliance (cGMP, GCP, Quality System Regulations), strategic quality planning, regulatory engagement, risk/benefit analysis, technical proposal review, sterile manufacturing knowledge, vaccine/therapeutic/diagnostic quality management
Preferred skills
Experience in chemical/biological/radiological/nuclear threat areas, medicinal chemistry, preclinical/clinical development, process scale-up, Total Life Cycle Cost management
Technologies
cGMP, GCP, Quality System Regulations, sterile manufacturing systems
Responsibilities
Advise BARDA senior leadership on critical quality issues; Provide training on regulations and compliance to federal staff; Review and comment on study protocols and regulatory documents; Serve as advisor on Technical Evaluation Panels; Develop expert assessment reports and technical summaries; Manage quality regulations across advanced development projects
Seniority
Senior, hands-on IC with strategic oversight
