Director, Quality Management Systems
Core
Designing, scaling, and advancing a global Quality Management System (QMS) to support the transition to commercial operations for a biopharma company developing neuromuscular disease therapeutics.
Role type
Director, Quality Management Systems (Strategic & Operational Leadership)
Builds
Global QMS framework including supplier quality, audit programs, and product complaint management systems
Domain
Biopharmaceuticals / Neuromuscular Therapeutics / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS) design and scaling, Supplier Quality management, Audit program execution, Product Complaint management, Risk-based quality strategy, Global regulatory alignment, Cross-functional partnership, Strategic vision, Operational execution
Preferred skills
Commercial operations transition experience, Inspection readiness preparation, Scalable system architecture
Technologies
QMS software platforms, Audit management tools, Complaint tracking systems
Responsibilities
Design and scale global QMS, Lead supplier quality programs, Manage audit programs, Oversee product complaint management, Ensure inspection readiness and regulatory alignment, Partner cross-functionally to embed quality as a strategic enabler