Global CMO Quality Manager & Compliance Lead

CSL; Argentina; On-site; ARS 137,543,000 - 213,956,000; Full time

Benefits offered by this job

Global travel

Competitive benefits

Job summary

CSL Seqirus in Argentina seeks a Manager, CMO Quality to oversee external manufacturing partners, ensuring GMP compliance, quality systems alignment with CSL Seqirus standards, and regulatory readiness across key markets.

You will lead CMO quality oversight for API, Fill/Finish and Packaging, draft and maintain Quality Agreements, manage CAPA and change control, and coordinate with global MAH stakeholders; expect ~25% travel to sites.

Qualifications

• Minimum 5 years in a GxP environment.
• Knowledge of FDA, EU GMP, PIC/S, TGA and Health Canada.
• Experience with CMOs / third-party quality management.
• Ability to work in a global matrix organization.

Responsibilities

• CMO Relationship & Quality Oversight: primary regional quality interface for CMOs.
• Quality Agreements & Governance: draft, negotiate and maintain CMO Quality Agreements.
• Deviation, CAPA & Change Management: review and approve deviations and CAPAs; manage changes.
• Performance Monitoring & Escalation: track KPIs; escalate critical quality issues.

Skills

Quality oversight

GxP experience

Regulatory knowledge

CMO management

Cross-functional leadership

Quality systems

Communication skills

Bilingual English/Spanish

Education

Bachelor's in Life Sciences

Job description

CSL Seqirus in Argentina seeks a Manager, CMO Quality to oversee external manufacturing partners, ensuring GMP compliance, quality systems alignment with CSL Seqirus standards, and regulatory readiness across key markets.

You will lead CMO quality oversight for API, Fill/Finish and Packaging, draft and maintain Quality Agreements, manage CAPA and change control, and coordinate with global MAH stakeholders; expect ~25% travel to sites.