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 global 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, and validation reports Performance Monitoring &

• Escalation - Track and report CMO quality performance through globally aligned KPIs - Identify quality trends and ensure timely corrective actions are implemented - Escalate critical quality issues to senior stakeholders and drive resolution Standardization &

• Continuous Improvement - Drive harmonization of quality processes across the CMO network (change management, batch record review, complaints, recalls) - Enhance CMO Quality Maturity and execute Quality Road Maps Regulatory &

• Inspection Support - Support regulatory inspections and audits at CMO sites as needed - Assess and communicate potential regulatory impacts on CSL Seqirus business Commercial Readiness &

• Growth - Support Tech Transfer, product launches, and regulatory submissions for new CMO projects - Act as Quality SME in cross-functional commercial readiness teams What You'll Bring Education - Bachelor's degree (or higher) in Pharmacy,



Chemistry, Biology, Biochemistry, or a related scientific discipline Experience - Minimum 5 years of experience in a GxP environment within the pharmaceutical, biotech, or regulated industry - Demonstrated knowledge of FDA, PIC/S, EU GMP, TGA, and Health Canada regulatory frameworks - Prior experience in CMO / third-party quality management highly preferred - Proven ability to work effectively in a integral matrix organization Skills &

Competencies - Strong quality system knowledge — internal and external manufacturing environments - Excellent organizational skills with the ability to manage multiple priorities across time zones - High cross-cultural sensitivity and interpersonal effectiveness - Managerial courage — able to hold compliance positions under pressure - Strategic mindset with strong decision-making and risk assessment capabilities - Outstanding written and verbal communication skills - Fluency in English and Spanish is required (written and spoken) What We Offer - A globally connected role with real impact on product supply and patient safety - Collaboration with world-class quality professionals across Americas, EMEA, and APAC - A culture that values integrity, courage, and continuous improvement - Competitive compensation and benefits aligned with multinational pharma standards - Approximately 25% travel to CMO sites and CSL Seqirus locations Our Commitment CSL Seqirus is committed to building a diverse, equitable, and inclusive workplace. We welcome applicants from all backgrounds and are proud to be an equal opportunity employer.

📌 Manager, CMO Quality Quality Assurance CSL Seqirus Buenos Aires, Buenos Aires, Argentina7 Posted on October 19, 2026
🏢 CSL
📍 Buenos Aires