My client is seeking a
Process Data Owner – AI Applications
to join the
Quality Systems & Strategy
team.
This role acts as both
Process Owner
and
Functional System Owner
for
AI-driven Quality solutions
within a
GxP-regulated environment
.
The primary objective is to lead the
development, validation, deployment, and industrialization of AI solutions
, while ensuring full regulatory compliance of prioritized AI initiatives.
Team Information
* Team size: 7 people
* Strong transversal collaboration with:
* Business
* Quality Digital Innovation
* Digital Technology
* Data Science
* External vendors
Key Responsibilities
* Lead the implementation of AI strategies for QA systems and data-driven decision support.
* Act as
Process Data Owner
for global AI-driven Quality Management Systems.
* Ensure global rollout, validation, and regulatory compliance of AI solutions.
* Monitor and interpret evolving guidelines and regulations (EMA, FDA, GxP, Data Integrity, AI guidance).
* Provide consultancy on AI, data science, and documentation in regulated environments.
* Be accountable for inspection and audit readiness of AI platforms.
* Build and maintain strong networks with key stakeholders and external partners.
* Define and track
KPIs and performance metrics
for AI systems and quality outcomes.
* Write, review, and approve:
* SOPs
* Change Controls
* Deviations
* Investigations
* CAPAs related to AI systems
What are we looking for?
Experience Requirements
* Minimum 2 years of hands-on experience in AI
* 7–8 years of total professional experience preferred
(flexible; maturity is key)
* Candidates with higher daily rates may be considered (within reasonable limits)
Must-Have Skills & Qualifications
* Strong expertise in
AI applied to Quality
, especially
LLMs
(non-negotiable)
* Solid understanding of
pharmaceutical compliance and GxP requirements
* Proven experience with
GxP computerized systems (CSV is mandatory)
* Knowledge of
Application Lifecycle Management (ALM)
* Experience deploying
2–3 enterprise application systems
* Excellent
communication and negotiation skills
* Ability to work directly with IT and senior stakeholders
* Fluent English required
; French is a strong plus
* Veeva experience
is a significant advantage
* AI / ML certifications
Nice to Have
* French language skills
* Experience in
digital transformation
within regulated environments
* Leadership experience in
multicultural and virtual teams