Senior Specialist, QA
Core
Ensures compliance of pharmaceutical, medical device, and cosmetic product quality systems from receipt through distribution, managing audits, supplier controls, and quality events.
Role type
Senior Specialist, Commercial Quality (QA)
Builds
Quality systems, procedures, and processes for drug, biologics, device, and cosmetic products
Domain
Life Sciences / Pharmaceutical Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP regulations knowledge, quality system design, audit support, supplier qualification, CAPA management, risk management, change control, KPI monitoring, cold chain monitoring
Preferred skills
Chemistry/Pharmacy/Biology degree, 3+ years QA/GMP/GDP experience, SAP/TrackWise/ComplianceWire/OneVault familiarity, subject matter expertise in specific quality areas
Technologies
SAP, TrackWise, ComplianceWire, OneVault
Responsibilities
Design effective quality systems and procedures; Plan, prepare, review, and approve quality documentation; Support internal, external, and regulatory audits; Coordinate and investigate quality events and deviations; Execute supplier qualification and performance monitoring; Monitor metrics and KPIs for compliance; Support Management Review process
Seniority
Senior, hands-on IC
