Global CMO Quality Manager — Compliance & Partnerships

CSL; Buenos Aires; On-site; ARS 181,747,000 - 242,329,000; Full time

Benefits offered by this job

Travel opportunities

Job summary

CSL Seqirus seeks a Manager, CMO Quality to ensure integrity and regulatory compliance across outsourced manufacturing networks for APIs, fill/finish, and packaging. You will partner with CMOs and QA teams to manage quality agreements, deviations, CAPAs, and GMP documentation.

The role requires 5+ years in a GxP environment, knowledge of global regulatory standards, and fluency in English and Spanish. Expect ~25% travel and global collaboration across Americas, EMEA, and APAC.

Qualifications

• Minimum 5 years of experience in a GxP environment within pharma/biotech/regulatory industries.
• Knowledge of FDA, PIC/S, EU GMP, TGA, Health Canada frameworks.

Responsibilities

• Serve as the primary regional quality interface for assigned CMOs and oversee quality systems.
• Draft, negotiate, and maintain CMO Quality Agreements per global regulations.
• Review and approve deviations, CAPAs, and GMP-controlled documents.
• Track quality performance with KPIs and escalate critical issues.
• Support regulatory inspections, tech transfer, and regulatory submissions.

Skills

GxP experience

Regulatory knowledge

CMO quality

Global matrix

English & Spanish

Education

Bachelor's degree in Pharmacy or related

Job description

CSL Seqirus seeks a Manager, CMO Quality to ensure integrity and regulatory compliance across outsourced manufacturing networks for APIs, fill/finish, and packaging. You will partner with CMOs and QA teams to manage quality agreements, deviations, CAPAs, and GMP documentation.

The role requires 5+ years in a GxP environment, knowledge of global regulatory standards, and fluency in English and Spanish. Expect ~25% travel and global collaboration across Americas, EMEA, and APAC.