Global CMO Quality Lead

CSL Vifor; City of Melbourne; Hybrid; AUD 140,000 - 190,000; Full time

Job summary

CSL Seqirus is seeking an experienced quality professional to join our Global External Quality team as Manager, CMO Quality. Reporting to the Global Head of CSL Seqirus External Quality, you will oversee quality for CMOs and outsourced manufacturing across a global network.

This role is based in a hybrid capacity at Tullamarine, with occasional travel to CSL sites as required. You will collaborate with Quality, Supply Chain, Regulatory Affairs, and Manufacturing to ensure safe, compliant, and

Qualifications

• Minimum 5 years' experience in a GxP-regulated pharmaceutical or biotechnology environment.
• Strong knowledge of global quality and regulatory requirements.
• Experience managing deviations, CAPAs, change controls and investigations.
• Proven ability to work in a complex global matrix environment.

Responsibilities

• Act as primary quality representative and key point of contact for assigned CMOs.
• Develop, negotiate, maintain, and oversee Quality Agreements with external manufacturing partners.
• Provide quality oversight for outsourced activities including API, fill-finish, packaging, and related operations.
• Review and assess deviations, investigations, CAPAs, change controls, and quality records.
• Monitor and report CMO quality performance through KPI tracking and trend analysis.
• Lead quality discussions during operational meetings, business reviews, and cross-functional project teams.
• Support technology transfers, commercial readiness activities, product launches, and lifecycle management initiatives.
• Facilitate issue resolution and ensure effective escalation and communication of critical quality concerns.
• Support regulatory inspections, audits, and responses relating to CSL Seqirus products manufactured at CMO sites.
• Drive standardization and continuous improvement across external quality systems and processes.

Skills

GxP knowledge

Quality systems

Stakeholder management

Communication skills

Regulatory knowledge

Negotiation

Cross-functional collaboration

Education

Bachelor's degree in science/Pharmacy/Engineering/Biotechnology/Quality

Job description

CSL Seqirus is seeking an experienced quality professional to join our Global External Quality team as Manager, CMO Quality. Reporting to the Global Head of CSL Seqirus External Quality, you will oversee quality for CMOs and outsourced manufacturing across a global network.

This role is based in a hybrid capacity at Tullamarine, with occasional travel to CSL sites as required. You will collaborate with Quality, Supply Chain, Regulatory Affairs, and Manufacturing to ensure safe, compliant, and