Global CMO Quality Lead, Compliance & Partnerships

CSL; Tandil; Presencial; ARS 181.747.000 - 227.183.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Global team collaboration

Travel ~25%

Competitive compensation

Diversity and inclusion culture

Descripción de la vacante

CSL Seqirus is seeking a Manager, CMO Quality to partner with our external manufacturing network across API, fill/finish and packaging. You will protect product quality, patient safety, and regulatory standing by overseeing CMO quality programs and governance.

This role requires leadership across time zones and strong collaboration with global stakeholders. You will drive harmonization of quality processes, manage deviations and CAPAs, and support regulatory inspections, tech transfers, and

Formación

• Bachelor's degree in a scientific discipline (Pharmacy/ Chemistry/ Biology).
• Minimum 5 years in a GxP environment within pharma/biotech or regulated industry.
• Knowledge of FDA, EMA, PIC/S, TGA, Health Canada frameworks.
• Experience with CMO/third-party quality management preferred.
• Ability to operate in a global matrix organization.

Responsabilidades

• Be the primary regional quality interface for assigned CMOs, fostering trusted partnerships.
• Ensure CMO quality systems align with CSL Seqirus standards and regulations.
• Review deviations, CAPAs, and changes; manage GMP documents and training.
• Monitor quality KPIs, escalate issues, and drive timely corrective actions.
• Support regulatory inspections and tech transfer activities as needed.
• Collaborate on product launches and regulatory submissions in cross‑functional teams.

Conocimientos

GxP

Quality systems

Regulatory knowledge

Stakeholder mgmt

Communication

Bilingual EN/ES

Educación

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Herramientas

QMS software

Descripción del empleo

CSL Seqirus is seeking a Manager, CMO Quality to partner with our external manufacturing network across API, fill/finish and packaging. You will protect product quality, patient safety, and regulatory standing by overseeing CMO quality programs and governance.

This role requires leadership across time zones and strong collaboration with global stakeholders. You will drive harmonization of quality processes, manage deviations and CAPAs, and support regulatory inspections, tech transfers, and