Manager, CMO Quality (Contract Manufacturing Organizations)

About the role

The Manager, CMO Quality reports to the Global Head of External Quality and serves as the primary quality partner for assigned Contract Manufacturing Organizations, overseeing outsourced production activities such as API, Fill/Finish, and Packaging.

Key responsibilities

• Serve as the main quality interface for CMOs, ensuring alignment with CSL Seqirus standards and regulatory requirements.
• Draft, negotiate, and maintain Quality Agreements in compliance with FDA, EMA, PIC/S, TGA, and Health Canada regulations.
• Review, assess, and approve CMO deviations, CAPAs, and change requests to maintain product quality.
• Track CMO performance through KPIs, identify trends, and drive corrective actions.
• Support regulatory inspections and audits at CMO sites and assist with tech transfer and product launches.

Required profile

• Minimum 5 years of experience in a GxP environment within pharma, biotech, or a regulated industry.
• Demonstrated knowledge of FDA, PIC/S, EU GMP, TGA, and Health Canada regulatory frameworks.
• Prior experience managing quality for CMOs or third‑party manufacturers.
• Ability to work effectively in a global matrix organization and travel up to 25%.

Required skills

• Strong knowledge of GxP quality systems.
• Experience with Quality Agreements, deviation and CAPA management.
• Familiarity with regulatory inspection support.
• Fluency in English and Spanish (written and spoken).

What we offer

• Globally connected role impacting product supply and patient safety.
• Collaboration with world‑class quality professionals across Americas, EMEA, and APAC.
• Competitive compensation and benefits aligned with multinational pharma standards.
• Approximately 25% travel to CMO sites and CSL Seqirus locations.