About CSL Seqirus
CSL Seqirus is one of the world's largest influenza vaccine companies and a global leader in pandemic preparedness. As part of the CSL Group, we operate at the intersection of cutting-edge science and meaningful human impact — protecting millions of lives every year. When you join CSL Seqirus, you join a team where quality is not a department, it's a commitment.
The Opportunity
Reporting to the Global Head of External Quality, the Manager, CMO Quality plays a critical role in ensuring the integrity, compliance, and continuity of our external manufacturing network. You will be the primary quality partner for assigned Contract Manufacturing Organizations (CMOs) — overseeing outsourced production activities including API, Fill/Finish, and Packaging — and serve as the trusted bridge between CSL Seqirus and our integral CMO partners.
This is a high-visibility, globally connected role where your decisions directly protect product supply, patient safety, and regulatory standing across multiple markets.
What You'll Do
CMO Relationship & Quality Oversight
• Serve as the primary regional quality interface for assigned CMOs, fostering strong, trust-based partnerships
• Ensure CMO quality systems are aligned with CSL Seqirus standards and applicable regulatory requirements
• Represent CSL Seqirus Quality in Joint Operational Meetings, Business Reviews, and on-site CMO visits
Quality Agreements & Governance
• Draft, negotiate, and maintain CMO Quality Agreements in compliance with FDA, EMA, PIC/S, TGA, and Health Canada regulations
• Oversee day-to-day execution of Quality Agreement commitments including training, recalls, and complaint management
Deviation, CAPA & Change Management
• Review, assess, challenge, and approve CMO deviations and CAPAs to ensure product quality and compliance
• Manage CMO-initiated changes and proactively communicate relevant updates to MAH stakeholders
• Review and approve GMP-controlled documents including SOPs, specifications,
📌 Manager, CMO Quality (Argentina)
🏢 CSL
📍 Argentina