Senior Quality Manager - Systems & Compliance
Core
Maintaining and continuously improving GxP Quality Systems to ensure inspection readiness and providing ongoing support and training to functions across MeiraGTx.
Role type
Senior Quality Manager (Systems & Compliance)
Builds
GxP compliant quality systems and inspection-ready operations
Domain
Pharmaceutical manufacturing & testing (sterile)
Required skills
GxP regulations, sterile manufacturing principles, Quality Management Systems, regulatory audit management, line management, quality risk management
Preferred skills
Quality culture facilitation, team development, decision making
Technologies
GxP regulations, Orange Guide, Eudralex Volume 4, 21CFR part 210/211
Responsibilities
Line management of the QA System & Compliance team, ensuring positive outcomes for regulatory inspections and client audits, managing team workload to meet timelines, promoting a culture of collaboration and quality coaching, ensuring training needs are met
Seniority
Senior, hands-on IC with line management responsibilities