Validation, Quality & Compliance Lead in Gaithersburg, Maryland at BULLFROG AI MANAGEMENT LLC

About BullFrog AI

BullFrog AI (NASDAQ: BFRG) is a computational biology company spun out of the Johns Hopkins Applied Physics Laboratory. We build AI-powered platforms that help pharmaceutical and biotech companies make better, faster decisions across the drug development lifecycle:

• bfPREP™ — biology-aware data harmonization that unlocks the value trapped in fragmented, multi-site clinical and omics datasets
• bfLEAP™ — causal AI analytics for patient subgroup discovery, biomarker identification, and drug target prioritization
• bfARENAS™ — structured multi-criteria decision support for high-stakes portfolio, indication, and go/no-go decisions

The Role

BullFrog AI is seeking a Validation, Quality & Compliance Lead to build and own the validation, quality, and compliance function from the ground up. This is a founding hire — the first person in this function — and a role that will grow into a team lead position as BullFrog scales.

Our platforms operate at the intersection of AI, real-world data, and clinical development, where the stakes of getting compliance right are high, and the regulatory landscape is evolving quickly. This person will be responsible for ensuring what we build meets the standards required by the pharmaceutical and biotech organizations we serve — and for helping us communicate the scientific rigor behind our work to the broader research community.

This is not a purely technical role and not a purely scientific one. The right candidate bridges both worlds: rigorous enough to evaluate code and compliance frameworks, credible enough to support peer-reviewed scientific publications, and strategic enough to build a function that scales with the company.

What You’ll Own

Validation & Regulatory Compliance

• Own BullFrog’s software validation framework — developing and maintaining validation documentation, protocols, and SOPs aligned to GxP standards relevant to pharma and biotech use cases
• Build the validation evidence, documentation, and operating practices needed to support customer use in regulated environments
• Partner with the data science and engineering teams to ensure validation requirements are embedded into the development lifecycle, not bolted on afterward

Build the documentation infrastructure — IQ/OQ/PQ protocols, change control processes, audit trails — that will support BullFrog’s expanding footprint in regulated customer environments

Code Security & Software Quality

• Work directly with the engineering team to assess and improve code security, identifying vulnerabilities and ensuring development practices meet software quality standards
• Implement and maintain security review processes, vulnerability tracking, and remediation workflows
• Develop and enforce QA standards across BullFrog’s platform suite, including testing frameworks, release criteria, and defect management processes
• Stay current on cybersecurity and software compliance requirements relevant to AI platforms handling clinical and real-world patient data

Scientific Publication Support

• Support scientific publications in collaboration with the data science team — contributing writing, editing, and structuring
• Ensure scientific claims are grounded in rigorous validation evidence and accurately represented in publication-ready materials
• Contribute to conference abstracts, posters, and presentations that advance BullFrog’s scientific credibility and commercial positioning

Function Building

• Define the roadmap for the Validation, Quality & Compliance function as BullFrog grows — identifying capability gaps, recommending hires, and establishing the practices that will support a larger team
• Expect to onboard and eventually manage a QA/CSV Validation Engineer and a Code Security/Compliance Engineer as part of BullFrog’s second hiring wave
• Serve as the internal subject matter expert and primary point of contact for all validation, compliance, and publication-related questions across the organization

What We’re Looking For

• 5+ years of experience in a validation, quality, compliance, or related function within a life sciences, biotech, pharma, or life sciences technology environment
• Direct hands-on CSV/GxP validation experience is required; mastery of every framework is not. We value candidates who can apply risk-based validation principles across 21 CFR Part 11, Annex 11, and GAMP 5 contexts.
• A plus: familiarity with code quality, software security review, or QA engineering — you are comfortable working directly with a technical team and reviewing code in context
• Preferred: experience supporting or leading scientific manuscript preparation and peer-reviewed journal submission processes; comfort with scientific writing at the level required for high-quality publication
• Ability to build from scratch — you have stood up processes, frameworks, or functions before and are energized by the absence of existing infrastructure, not frustrated by it
• Strong cross-functional communication: you can translate compliance requirements for engineers and scientific rigor requirements for business stakeholders
• Must be legally authorized to work in the United States

Who Will Thrive Here

• A builder — motivated by creating something that doesn’t exist yet and owning it through to maturity
• Intellectually versatile — energized by the breadth of this role rather than looking for a narrower lane
• Scientifically curious — you find the biology and the data genuinely interesting, and that shows in the quality of your work
• Highly organized and detail-oriented — validation and publication work are unforgiving; you close every loop and document everything
• Growth-oriented — you approach this founding role as preparation for leading a team, not just executing a job description

What We Offer

Base salary range: $130,000–$160,000, based on a combination of relevant experience, skills, and location. This role is eligible for performance bonus and equity/stock options, subject to company and plan terms. Full benefits, including medical, dental, and vision from day one, short-term disability, 401(k) from first paycheck, 15 days PTO, 11 paid holidays annually, and maternity and paternity leave.