FDA Inspections Subject Matter Expert (SME)

The FDA Inspections SME will provide expert guidance and leadership for GDIT’s SIRCE opportunity, leveraging deep knowledge of FDA regulatory requirements, inspection protocols, and digital transformation initiatives. This role is ideal for a professional who has played a pivotal role in developing and implementing FDA inspection systems such as eNSPECT, and who can bridge regulatory, operational, and IT domains to drive enterprise compliance and innovation.

Key Responsibilities:

• Serve as the enterprise lead for all FDA inspection-related subject matter, providing authoritative guidance on regulatory requirements, inspection protocols, and compliance strategies.
• Advise on the design, development, and implementation of digital inspection systems, drawing on experience with FDA’s eNSPECT or similar platforms.
• Collaborate with cross-functional teams (IT, regulatory, operations, and business development) to ensure SIRCE solutions meet FDA standards and client expectations.
• Develop and deliver training, documentation, and best practices for FDA inspections and digital system adoption.
• Analyze and interpret FDA regulations, guidance documents, and inspection trends to inform enterprise strategy and client proposals.
• Represent GDIT in client meetings, industry forums, and with FDA stakeholders as the recognized inspections SME.
• Support proposal development, technical solutioning, and program execution for FDA-related opportunities.

Required Skills and Experience:

• Bachelor’s degree and 12+ years of experience or advanced degree in life sciences, public health, regulatory affairs, or a related field (Master’s or PhD preferred for SME level)
• 8+ years of experience in FDA regulatory compliance, inspections, or digital transformation within the FDA or regulated industry.
• Demonstrated expertise in FDA inspection processes, including hands-on experience with eNSPECT or similar inspection management systems.
• Proven ability to translate regulatory requirements into operational and technical solutions.
• Experience supporting large-scale federal health IT or regulatory compliance programs is highly desirable.

Desired Skills and Experience:

• FDA regulatory compliance
• Inspection management and digital transformation (e.g., eNSPECT)
• Regulatory affairs and policy interpretation
• Stakeholder engagement and training
• Project management and cross-functional leadership
• Technical writing and documentation
• Strong communication, stakeholder engagement, and leadership skills.