Senior QA Manager ESO Biosimilars, LM
Core
Ensures manufacturing, testing, release, and distribution of biologics and sterile pharmaceutical products at external supplier sites comply with cGMP and regulatory requirements.
Role type
Senior QA Manager (External Supplier Oversight)
Builds
External supplier quality oversight and compliance for biologics/sterile products
Domain
Pharmaceutical manufacturing (Biologics/Sterile)
Required skills
cGMP compliance, sterile pharmaceutical processes, biologics manufacturing, risk management, quality audits, incident management, change control, process transfer oversight, KPI monitoring, regulatory affairs (FDA/EMEA)
Preferred skills
Project management, negotiation, decision-making, people management
Technologies
None stated
Responsibilities
Formulate strategies to maintain and improve external supplier quality oversight; Act as Single Point of Contact for quality activities at external suppliers; Manage supplier qualification, quality agreements, and risk assessments; Monitor quality trends, stability reports, and annual product quality reviews; Manage quality incidents, deviations, and OOX; Oversee change controls and manufacturing/analytical method transfers; Monitor KPIs and initiate corrective actions; Escalate critical quality issues to management.
