Executive Director, QMS AI Quality & Compliance- fully remote!

Thermo Fisher Scientific•Morrisville, NC

15h•Remote

About The Position

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and supporting our customers’ medical related inquiries. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us. What will you do in this role? The Executive Director, QMS AI Quality & Compliance CRG is a high-impact, strategic leadership role responsible for transforming the company’s Quality Management System (QMS) into an intelligent, data-driven, and proactive framework. This role bridges the gap between Quality Assurance and Information Technology, driving the migration from legacy systems to modern eQMS platforms, implementing AI-driven predictive analytics for compliance, and ensuring the validation and integrity of data in a GxP environment. Qualification requirements:

Requirements

Bachelor’s degree in Pharmacy, Engineering, Data Science, or a related Life Science field; Master’s degree preferred. I n some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
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.
Experience moving from rigid, paper-based processes to flexible, software-driven quality systems.
Ability to manage data quality during migration and ensure compliance with evolving digital standards.
Shifting quality from a gatekeeper to a proactive business enabler.
Ability to bridge the gap between technical teams (data science) and non-technical stakeholders (clinical, operations, legal, business).
Strong understanding of fairness, bias detection, and human-in-the-loop concepts.
Ability to communicate complex ethical, and technical concepts to cross functional colleagues and senior leadership.
Must be legally authorized to work in the US without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.