External Quality Operations Manager
Core
Ensure quality oversight of external manufacturing partners (CMOs) and support the reliable supply of high-quality medicines.
Role type
Senior IC quality operations manager (pharmaceuticals)
Builds
Reliable supply of high-quality medicines
Domain
Pharmaceuticals / Biotechnology / Life Sciences
Required skills
Pharmaceutical QA operations, GMP, GDP, CMO management, Quality Technical Agreements, Quality Risk Assessment, CAPA management, Change control, Health Authority inspections, Batch release qualification
Preferred skills
Global operations experience, FDA/EMEA inspection experience, Risk management tools, KPI assessment and improvement
Technologies
GMP, GDP, QTA, APQR, PQR
Responsibilities
Act as single point of contact for quality activities at CMOs; Ensure compliance with Sobi Quality system and CGMP requirements; Support product release as QP Delegate; Manage/approve quality issues (deviations, CAPA, complaints); Ensure Quality Audits of CMOs are performed; Lead strategy for quality transformation initiatives; Assess CMO readiness for Health Authorities inspections.
Seniority
Senior, hands-on IC
