Senior Director, QMS AI Quality & Compliance
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Job Level
About the role
- Responsible for transforming the company’s Quality Management System (QMS) into an intelligent, data-driven, and proactive framework.
- Bridges the gap between Quality Assurance and Information Technology.
- Drives the migration from legacy systems to modern eQMS platforms.
- Implements AI-driven predictive analytics for compliance.
- Ensures the validation and integrity of data in a GxP environment.
- Shifts the quality function from a "gatekeeper" to a "proactive business enabler" for the 2025–2026 landscape.
Requirements
- Bachelor’s degree in Pharmacy, Engineering, Data Science, or a related Life Science field; Master’s degree preferred.
- 10–15+ years in pharmaceutical quality leadership, with at least 5+ years specializing in AI governance, data strategy, or digital quality transformation is required.
- A minimum of 5 years of direct people management is required.
- Deep understanding of Machine Learning in root cause analysis, GenAI, and agentic AI pipelines is required.
- Proven track record of leading large-scale eQMS implementation (e.g., Veeva, ETQ) and data migration projects is required.
- Strong ability to influence cross-functional teams and drive change management from "traditional" to "Agile" quality systems is required.
Benefits
- Relocation assistance is NOT provided
- Comprehensive background check, which includes a drug screening
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management System (QMS)AI-driven predictive analyticsMachine Learningdata strategydigital quality transformationeQMS implementationdata migrationroot cause analysisGenAIagentic AI pipelines
Soft Skills
people managementinfluence cross-functional teamschange managementproactive business enablingleadership