CSL Seqirus is one of the world's largest influenza vaccine companies and a integral 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
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 global matrix organization
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.
About CSL Seqirus
CSL Seqirus is part of CSL.
As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are.
It fuels our innovation day in and day out.
By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer.
If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit .
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📌 Manager, Cmo Quality (Contract Manufacturing Organizations) - Csl Seqirus (Buenos Aires)
🏢 CSL
📍 Buenos Aires