Manager, CMO Quality

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. This high‑visibility role ensures product supply integrity, patient safety, and regulatory compliance across multiple markets.

Key responsibilities

• Act as the regional quality interface for CMOs, aligning their quality systems with CSL Seqirus standards and regulatory requirements.
• Draft, negotiate, and maintain Quality Agreements; oversee day‑to‑day execution including training, recalls, and complaint management.
• Review, assess, and approve CMO deviations, CAPAs, and change requests to ensure compliance.
• Track CMO performance through KPIs, identify trends, and drive corrective actions.
• Support regulatory inspections and audits at CMO sites and contribute to tech transfer, product launches, and regulatory submissions.

Required profile

• Bachelor’s degree or higher in Pharmacy, Chemistry, Biology, Biochemistry, or related scientific discipline.
• Minimum 5 years of experience in a GxP environment within the pharmaceutical, biotech, or regulated industry.
• Demonstrated knowledge of FDA, PIC/S, EU GMP, TGA, and Health Canada regulations.
• Prior experience managing quality for CMOs or third‑party manufacturers is highly preferred.
• Fluency in written and spoken English and Spanish.

Required skills

• Strong knowledge of internal and external quality systems.
• Excellent organizational ability to manage multiple priorities across time zones.
• Effective communication skills for cross‑cultural and senior stakeholder interactions.

What we offer

• Global impact on 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.