Quality Project Lead
Core
Lead quality systems and investigations to ensure regulatory compliance and continuous improvement in pharmaceutical manufacturing operations.
Role type
Quality Project Lead (Quality Specialist III)
Builds
Quality systems, investigation reports, SOPs, and audit outcomes for drug development and commercial manufacturing.
Domain
Pharmaceutical manufacturing (Oral Solid Dose)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GxP regulations knowledge, root cause analysis, CAPA management, change control, audit management, statistical analysis, technical writing
Preferred skills
Project management, risk assessment methodologies, quality systems software proficiency
Technologies
TrackWise, document control systems
Responsibilities
Maintain quality systems in compliance with cGMPs and global regulations; Lead and support investigations related to deviations and quality events; Manage and support CAPA, change control, and risk assessment activities; Author, review, and approve SOPs and quality documentation; Conduct and host internal and external audits and regulatory inspections; Analyze quality data and report metrics to support continuous improvement
Seniority
Mid-level, hands-on IC
