Associate Director - QMS Manager
Core
Lead the maintenance, development, and optimization of the Quality Management System (QMS) and GMP training program for a multi-product GMP biotech contract manufacturing environment.
Role type
Associate Director, Quality Management System (QMS) Manager
Builds
Global Quality Assurance (QA) GMP systems initiatives across the Lonza network
Domain
Biotechnology / Contract Manufacturing / Pharmaceutical Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations knowledge (FDA, EU, MHRA, PIC/S), Quality systems platform experience (Veeva, TrackWise), strategic leadership, data-led improvement analysis, internal audit execution, regulatory inspection support, Qualified Person (QP) regulatory compliance
Preferred skills
Qualified Person (QP) status or active progression toward certification
Technologies
Veeva, TrackWise
Responsibilities
Lead the development and continuous improvement of the QMS, Ensure compliance with GMP regulations and global quality standards, Monitor QMS performance metrics and drive data-led improvements, Oversee GMP training programmes and ensure ongoing compliance, Partner with site leadership to align quality, training and business objectives, Lead internal audits and support customer and regulatory inspections, Act as a subject matter expert for quality systems across the site and global network, Perform the duties of a Qualified Person (QP) when appropriately qualified and required
Seniority
Senior, strategic leadership & department direction