Associate Director - Quality - Laboratory Services
Core
Strategic Quality leadership and oversight for three Laboratory Services sites across the U.S. and France, driving a harmonized Quality Management System (QMS) and ensuring regulatory compliance.
Role type
Associate Director, Quality (Laboratory Services)
Builds
Laboratory Quality Management System (QMS), regulatory compliance frameworks, and inspection readiness.
Domain
Medical Technology / Life Sciences / Laboratory Services
Required skills
Quality strategy & governance, QMS leadership (cGMP, ISO/IEC 17025, ISO 13485), regulatory inspection readiness, risk management, team leadership, cross-functional stakeholder influence, data integrity principles, LIMS implementation
Preferred skills
French language proficiency
Technologies
LIMS, QMS software
Responsibilities
Define and execute Quality strategy for the laboratory network; Establish governance across three laboratories; Lead continuous improvement of the QMS; Maintain readiness for regulatory inspections and customer audits; Provide oversight of nonconformances, investigations, and CAPAs; Lead Quality aspects of laboratory transformation and digitalization
Seniority
Senior, hands-on IC with leadership responsibilities
