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.
#J-*****-Ljbffr

📌 Manager, Cmo Quality (Tandil)
🏢 CSL
📍 Tandil