HEALTHCARE COMPLIANCE · GLOBAL REGULATORY STRATEGY · AI GOVERNANCE
Tanisha TejadaThoreau
Quality Assurance · Auditor · Regulatory Chemist · JD Candidate · ISO 42001 Certified AI Governance Leader
I translate dense, multi-layered regulation into operations your teams can actually run — and defend. Over a decade in the wet lab, twelve years in global quality auditing, and a legal education built specifically to close the gap between science and law.
Nurse
→
Analytical Chemist
→
Lab Quality Director
→
Regulatory & Legal Strategist
Permanent
Temporary
Short-Term
Contract / Advisory
— remote, on-site, or hybrid, across four continents.
⚠ Urgent Compliance Briefing
Unregulated AI Is Your Company’s Biggest Unseen Legal Threat
Why “closed” corporate AI tenants won’t save you from the FDA — and what to do about it.
Watch Tanisha’s 7-minute executive briefing on frontier AI risks, StarLIMS integration vulnerabilities, and FDA 21 C.F.R. § 211.22 compliance. ~7:44 min
Why “Closed-Tenant” AI Systems Still Expose Life Science Corporations to FDA Citations and Director Liability
Executives assume commercial tools like Microsoft 365 Copilot are safe because vendor SLAs guarantee tenant data isolation. They’re wrong. Vendor SLAs don’t protect against internal over-permissioning, indirect prompt injection, or non-compliance with non-delegable FDA Quality Control Unit mandates under 21 C.F.R. § 211.22.
When enterprise AI interfaces with structured databases like Abbott’s StarLIMS, unmonitored model drift can trigger accidental clinical trial unblinding, data integrity invalidation, and personal Caremark fiduciary liability for corporate officers.
My capstone paper introduces The Algorithmic Audit Doctrine — a 4-pillar governance model and operational Algorithmic Quality Assurance (AQA) framework built to protect life science firms from FDA BIMO inspection penalties, trial invalidation, and Caremark director liability.
Algorithmic Quality Assurance (AQA) Readiness — A 3-Phase Advisory Model
01
30 Days
Closed-Tenant GxP & Permissioning Assessment
Audits enterprise AI tools against internal GxP drives, LIMS exports, and SharePoint repositories. Identifies over-permissioning risk and verifies prompt logs against FDA 21 C.F.R. § 211.194 and GDPR Article 17.
02
60 Days
AQA Governance SOP Framework
Drafts SOPs for Algorithmic Competency Assurance (ISO/IEC 17025 blind control testing) and human-in-the-loop review protocols, protecting leadership under FDA BIMO and Caremark standards.
03
90 Days
Cross-Functional AQA Sub-Unit
Charters an integrated team across IT Architecture, Wet-Lab Quality, and Legal Compliance — targeting Level 4/5 on the Algorithmic Maturity Model.
THE BRIDGE
Science, Strategy, and Governance — in one hire.
Organizations rarely struggle with regulation because they lack rules — they struggle because no one on staff can move fluently between the legal mandate, the quality system, and the wet-lab reality. I built my career to be that connective tissue: a strategic cross-functional bridge linking Clinical Chemistry, Quality Assurance, IT Architecture, and Legal Compliance.
I take dense, multi-layered regulatory frameworks and translate them into bite-sized, actionable, defensible operations that move organizations from reactive to proactive compliance.
That fluency comes from having done the work at every layer of the stack — from bedside nursing, to method development at the bench, to directing laboratory quality programs, to studying the law that governs all of it. Most candidates can speak one of those languages. I speak all four, which is why I’m brought in when the stakes are highest and the timeline is shortest.
Nurse. Chemist. Lawyer. One lens.
CAREER PATHWAY
Four disciplines. One continuous thread.
Each stage built the fluency the next one required — with project management as the throughline connecting all of them.
Nursing
Patient care grounded in protocol, precision, and accountability under pressure.
Analytical Chemist
Mass Spectrometry Specialist & Method Development Chemist
Lab Quality Leadership
Global Clinical QA Lead Auditor directing risk-based programs across FDA, DEA, CLIA, CAP & ISO.
Regulatory & Legal Strategy
JD Candidate applying legal rigor to compliance architecture and AI governance.
Threaded through every stage: high-velocity project management — guiding cross-functional teams through complex scaling without compromising data integrity.
TRACK RECORD & EXPERTISE
Built for high-stakes, many-moving-parts environments.
A decade as a research chemist, twelve years in global quality auditing, and experience spanning startup labs to multinational corporations.
01
ISO 42001 AI Governance
Certified AI Governance Leader applying an emerging standard of care to algorithmic systems operating inside regulated, GxP environments.
EMERGING STANDARD
02
Global Enterprise Governance
As Global Clinical QA Lead Auditor for corporate entities including ACM Global Laboratories, directed risk-based audit programs across FDA, DEA, ICH E6(R3), CLIA, CAP, and ISO standards.
ENTERPRISE SCALE
03
Startup Agility & Expansion
Regularly contracted by startups to build inspection-ready Quality Management Systems from the ground up, guiding teams through scaling phases without compromising data integrity.
CONTRACT-READY
04
National Crisis Response
Selected as a Subject Matter Expert during Operation Warp Speed, serving as a critical liaison between clinical research teams and regulatory bodies to accelerate COVID-19 vaccine trials under compressed timelines.
NATIONAL PROGRAM
05
Method Development & Adaptability
Developed and validated analytical methods early in my career. Lived and worked across 18 states and 3 countries, proving adaptability in any environment.
BENCH TO BOARDROOM
06
Academic Honors
Member, Phi Theta Kappa. Formal training spans nursing, chemistry, biotechnology, and law — each degree chosen to close a specific capability gap.
CROSS-DISCIPLINARY
07
GCP Clinical Trial Audit
Good Clinical Practice (GCP) Audit (21 CFR Parts 50, 54, 56, 312): Illustrates rigorous clinical trial oversight, investigator compliance, and triangular data verification used to identify root-cause procedural discrepancies.
CLINICAL TRIAL INTEGRITY
08
GCLP & Multi-Standard Lab Audit
GCLP & Multi-Standard Laboratory Audit (CLIA, CAP, NYSDOH, ISO 15189, ISO 42001): Showcases a comprehensive wet-lab quality systems review balancing analytical controls, data integrity, and emerging AI model governance.
LAB QUALITY SYSTEMS
09
Algorithmic Audit Doctrine (AAD)
Algorithmic Audit Doctrine (AAD) Assessment: Demonstrates how the 4-Pillar framework audits enterprise AI deployments against FDA 21 CFR § 211, ISO 42001, and Caremark director oversight standards.
4-PILLAR FRAMEWORK
CORE EXPERTISE
What I bring to the team on day one.
AI Governance
ISO 42001 (AI Management Systems) & ISO 27001 (Information Security); enterprise AI compliance systems and algorithmic chain-of-custody frameworks for regulated environments.
Global Regulatory Strategy
Quality & Medical: ISO 9001, ISO 13485 (Medical Devices), ISO 14971 (Risk Management), ISO 15189 (Medical Labs), ISO 17025 (Testing Labs), FDA, EMA, MHRA, ICH GCP — regulatory architecture that holds up across jurisdictions.
Legal & Regulatory Strategy
JD candidate applying legal-grade rigor to compliance architecture, director liability exposure, and regulatory defensibility.
Clinical Compliance
Auditor: GxP, 21 CFR Parts 50, 54, 56, and 312 — human subjects protection, IRB oversight, and IND compliance.
HOW I WORK
The operating philosophy behind the resumé.
01
Adaptability First
Regulatory environments change, technologies evolve, and teams pivot. I stay grounded through the pace of it — and having worked across 18 states and 3 countries, I adapt quickly to new corporate cultures and regulatory environments.
02
Relational Niche Integration
I quickly identify where I add immediate value inside an organization without disrupting existing workflows, and I build strong working relationships across departments from day one.
03
Autonomous Exploration to Team Leadership
Equally comfortable working solo — scoping projects and auditing gap areas — as I am building, mentoring, and leading cross-functional teams to execute on what I find.
LET’S TALK
Available now — on your terms.
Whether exploring opportunities or targeted regulatory projects, I welcome the conversation.
Permanent
Temporary
Short-Term
Contract / Advisory
Remote & On-Site
📍 Remote / Open to Select Travel