FDA Inspections Subject Matter Expert (SME)

Type of Requisition:

Regular

Clearance Level Must Currently Possess:

None

Clearance Level Must Be Able to Obtain:

None

Public Trust/Other Required:

None

Job Family:

Science and Research

Job Qualifications:

Skills:

Cross-Functional Teamwork, Digital Transformation Initiatives, Functional Leadership, Regulatory Compliance, Regulatory Requirements

Certifications:

None

Experience:

10 + years of related experience

US Citizenship Required:

No

Job Description:

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.

 

The likely salary range for this position is $31,450 - $42,550. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Scheduled Weekly Hours:

8

Travel Required:

Less than 10%

Telecommuting Options:

Hybrid

Work Location:

Any Location / Remote

Additional Work Locations:

Total Rewards at GDIT:

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. GDIT typically provides new employees with 15 days of paid leave per calendar year to be used for vacations, personal business, and illness and an additional 10 paid holidays per year. Paid leave and paid holidays are prorated based on the employee’s date of hire. The GDIT Paid Family Leave program provides a total of up to 160 hours of paid leave in a rolling 12 month period for eligible employees. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

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Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans