Global CMO Quality Manager - Risk & Compliance Leader

CSL; Buenos Aires; Hybrid; ARS 136,310,000 - 181,747,000; Full time

Benefits offered by this job

Global exposure

Travel 25%

Competitive pay

Job summary

CSL Seqirus is seeking a Manager, CMO Quality to ensure integrity and compliance across outsourced manufacturing networks, including API, Fill/Finish, and Packaging. You will partner with CMOs, drive quality governance, and influence regulatory outcomes globally.

The role requires 5+ years in GxP, strong regulatory knowledge (FDA, EMA, PIC/S, TGA, Health Canada), and fluency in English and Spanish. Occasional travel and cross-functional leadership are integral to success.

Qualifications

• Bachelor's degree in a scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• Minimum 5 years in a GxP environment within pharma/regulated industry
• Knowledge of FDA, PIC/S, EU GMP, TGA and Health Canada requirements
• Prior CMOs/third-party quality management experience preferred
• Experience working in a global matrix organization

Responsibilities

• CMO Relationship & Quality Oversight: act as primary regional quality interface with CMOs and ensure alignment with CSL Seqirus standards and regulatory requirements
• Quality Agreements & Governance: draft/ negotiate and maintain CMO quality agreements per FDA/EMA/PIC/S/TGA/Health Canada regulations
• Deviation, CAPA & Change Management: review and approve CMOs' deviations/CAPAs and manage change initiatives
• Performance Monitoring & Escalation: track CMO quality KPIs and escalate critical issues to senior stakeholders
• Standardization & Continuous Improvement: harmonize quality processes across CMO network and drive quality road maps
• Regulatory & Inspection Support: support regulatory inspections and communicate potential regulatory impacts
• Commercial Readiness & Growth: support Tech Transfer, product launches, and regulatory submissions in cross-functional teams

Skills

Quality management

GxP knowledge

Regulatory frameworks

Cross-functional leadership

English & Spanish fluency

Global matrix collaboration

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology

Job description

CSL Seqirus is seeking a Manager, CMO Quality to ensure integrity and compliance across outsourced manufacturing networks, including API, Fill/Finish, and Packaging. You will partner with CMOs, drive quality governance, and influence regulatory outcomes globally.

The role requires 5+ years in GxP, strong regulatory knowledge (FDA, EMA, PIC/S, TGA, Health Canada), and fluency in English and Spanish. Occasional travel and cross-functional leadership are integral to success.