Quality Assurance Manager, Operations
Core
Lead a team supporting GMP compliance and quality oversight across site operations in a regulated manufacturing environment.
Role type
Senior IC Quality Assurance Manager (Operations)
Builds
Quality systems, processes, and overall site compliance for biotechnology/pharmaceutical manufacturing
Domain
Biotechnology / Pharmaceutical / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations knowledge, team leadership, deviation/CAPA/change control management, cross-functional collaboration, regulatory alignment, quality metrics tracking
Preferred skills
TrackWise, SAP, Syncade, Microsoft Office tools
Responsibilities
Lead and manage a team of QA Compliance Specialists and QA Project Managers, Provide guidance and act as a point of escalation for quality-related issues, Ensure alignment with regulatory requirements and internal SOPs, Partner cross-functionally to resolve complex quality issues, Oversee and track quality metrics including deviation trending, Perform and support lot release and disposition activities, Drive continuous improvement initiatives to enhance quality systems
Seniority
Senior, hands-on IC with team leadership
