About CSL SeqirusCSL 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 OpportunityReporting 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 DoCMO Relationship & Quality OversightServe as the primary regional quality interface for assigned CMOs, fostering strong, trust-based partnershipsEnsure CMO quality systems are aligned with CSL Seqirus standards and applicable regulatory requirementsRepresent CSL Seqirus Quality in Joint Operational Meetings, Business Reviews, and on-site CMO visitsQuality Agreements & GovernanceDraft, negotiate, and maintain CMO Quality Agreements in compliance with FDA, EMA, PIC/S, TGA, and Health Canada regulationsOversee day-to-day execution of Quality Agreement commitments including training, recalls,



and complaint managementDeviation, CAPA & Change ManagementReview, assess, challenge, and approve CMO deviations and CAPAs to ensure product quality and complianceManage CMO-initiated changes and proactively communicate relevant updates to MAH stakeholdersReview and approve GMP-controlled documents including SOPs, specifications, and validation reportsPerformance Monitoring & EscalationTrack and report CMO quality performance through globally aligned KPIsIdentify quality trends and ensure timely corrective actions are implementedEscalate critical quality issues to senior stakeholders and drive resolutionStandardization & Continuous ImprovementDrive harmonization of quality processes across the CMO network (change management, batch record review, complaints, recalls)Enhance CMO Quality Maturity and execute Quality Road MapsRegulatory & Inspection SupportSupport regulatory inspections and audits at CMO sites as neededAssess and communicate potential regulatory impacts on CSL Seqirus businessCommercial Readiness & GrowthSupport Tech Transfer, product launches, and regulatory submissions for new CMO projectsAct as Quality SME in cross-functional commercial readiness teamsWhat You'll BringEducationBachelor's degree (or higher) in Pharmacy, Chemistry,



Biology, Biochemistry, or a related scientific disciplineExperienceMinimum 5 years of experience in a GxP environment within the pharmaceutical, biotech, or regulated industryDemonstrated knowledge of FDA, PIC/S, EU GMP, TGA, and Health Canada regulatory frameworksPrior experience in CMO / third-party quality management highly preferredProven ability to work effectively in a general matrix organizationSkills & CompetenciesStrong quality system knowledge — internal and external manufacturing environmentsExcellent organizational skills with the ability to manage multiple priorities across time zonesHigh cross-cultural sensitivity and interpersonal effectivenessManagerial courage — able to hold compliance positions under pressureStrategic mindset with strong decision-making and risk assessment capabilitiesOutstanding written and verbal communication skillsFluency in English and Spanish is required (written and spoken)What We OfferA globally connected role with real impact on product supply and patient safetyCollaboration with world-class quality professionals across Americas, EMEA, and APACA culture that values integrity, courage, and continuous improvementCompetitive compensation and benefits aligned with multinational pharma standardsApproximately 25% travel to CMO sites and CSL Seqirus locationsOur CommitmentCSL 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.
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📌 Manager, Cmo Quality (Tandil)
🏢 CSL
📍 Tandil