Quality Assurance Manager*in (m/w/d) Operations
Core
Design and develop a GMP-compliant Quality Management System (QMS) for a new Life Science operations site, ensuring regulatory compliance and operational quality.
Role type
Quality Assurance Manager (Operations)
Builds
GMP-compliant quality management processes and standards for a new Life Science manufacturing/testing facility.
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Assurance
Required skills
GMP compliance, risk management, CAPA management, change management, deviation management, complaint management, escalation management, KPI analysis, audit execution, SOP development
Preferred skills
Pharmaceutical manufacturing knowledge, chemical/biochemical/microbiological analytics
Technologies
GMP, CAPA, SOPs, KPIs
Responsibilities
Identify QA tasks and implement necessary actions; onboard and support QA team members; ensure compliance with national and international GMP requirements; execute QA processes including risk, deviation, CAPA, training, change, batch documentation, complaint, and escalation management; participate in interdisciplinary discussions on QMS conformity; handle initial contact for quality events; collect and evaluate KPIs; conduct and evaluate GMP audits; provide on-call support for GMP-relevant reports.
Seniority
Mid-Senior, hands-on IC
