Associate 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
Associate Director, Quality Management Systems
Builds
Global QMS infrastructure, document control systems, and training programs for a biopharma company
Domain
Biopharmaceuticals / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS strategy, regulatory compliance (ICH Q10, FDA CFRs), risk-based process design, document lifecycle management, training program governance, inspection readiness, cross-functional leadership
Preferred skills
Commercial operations experience, eDMS/LMS implementation, accelerated timeline management
Technologies
eDMS, LMS
Responsibilities
Lead the evolution of the QMS into a commercial-ready, globally scalable system; Ensure QMS processes are phase-appropriate, risk-based, and designed to scale; Establish and sustain a proactive compliance model; Serve as a subject matter expert during regulatory inspections; Provide strategic and operational leadership for GxP documentation and training programs; Oversee the end-to-end lifecycle management of quality documents; Drive high-volume document authoring, revision, and implementation; Lead the planning, deployment, and governance of role-based training curriculum; Lead the design and implementation of learning programs; Manage the day-to-day delivery of programs; Drive development and review of engaging learning materials and assessments; Lead technical sessions to scale eDMS/LMS capabilities.
Seniority
Senior, hands-on IC with strategic vision