LSA QA Sr. Compliance Specialist
Core
Subject matter expert for Quality Systems and GMP Compliance driving inspection readiness and strengthening quality systems across a pharmaceutical manufacturing site.
Role type
Senior IC Quality Assurance Compliance Specialist
Builds
Quality systems, regulatory compliance posture, and inspection readiness for pharmaceutical/biotech manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance expertise, deviation/CAPA/change control management, regulatory inspection support, quality metrics analysis, cross-functional collaboration, technical writing
Preferred skills
cGMP regulations knowledge (FDA 21 CFR Parts 210/211, EU GMP Annex 1, ICH), eQMS proficiency (TrackWise, Veeva, MasterControl), Life Sciences/Chemistry/Biology/Engineering degree
Technologies
TrackWise, Veeva, MasterControl
Responsibilities
Lead Quality Review Boards (Deviation, CAPA, Change Control, Quality Council); Review and approve deviations, investigations, CAPAs, change controls, SOPs; Identify compliance gaps and drive corrective actions; Support internal, customer, and regulatory audits; Generate and trend quality metrics/KPIs; Provide GMP guidance and training to cross-functional teams
Seniority
Senior, hands-on IC
