Manager, CMO Quality

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

We are seeking an experienced quality professional to join our Global External Quality team as a Manager, CMO Quality. Reporting to the Global Head of CSL Seqirus External Quality, you will provide quality oversight of Contract Manufacturing Organizations (CMOs) and outsourced manufacturing operations across a global network.

This is a highly visible role responsible for building strong relationships with external manufacturing partners, ensuring compliance with global quality standards, and supporting commercial readiness, technology transfer activities, and ongoing manufacturing operations. You will work collaboratively with Quality, Supply Chain, Manufacturing, Regulatory Affairs, and Technical Operations teams across multiple regions to ensure the delivery of safe, compliant, and high-quality products.

This role will be based in a hybrid capacity at Tullamarine, with occasional travel required to other CSL sites as business needs dictate.

Key Responsibilities

As Manager, CMO Quality, you will:

• Act as the 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.

About You

To be successful in this role, you will bring:

Essential

• Bachelor's degree in science, Pharmacy, Engineering, Biotechnology, Quality, or a related discipline.
• Minimum 5 years' experience working in a GxP-regulated pharmaceutical or biotechnology environment.
• Strong knowledge of global quality and regulatory requirements, including FDA, PIC/S, European regulations, TGA, and other international standards.
• Experience managing deviations, CAPAs, change controls, investigations, and quality systems.
• Proven ability to work effectively within a complex global matrix environment.
• Strong stakeholder management and relationship-building skills.
• Excellent communication, negotiation, and influencing abilities.

Highly Desirable

• Previous experience managing quality oversight of Contract Manufacturing Organizations (CMOs).
• Experience supporting technology transfer, external manufacturing, or commercial readiness activities.
• Experience supporting regulatory inspections and external audits.
• Demonstrated success leading cross-functional projects and driving process improvements.

Why Join CSL Seqirus?

• Work within a globally recognised biotechnology leader.
• Influence the quality performance of a diverse global manufacturing network.
• Collaborate with international stakeholders and industry experts.
• Contribute to products that protect millions of people worldwide.
• Be part of a culture focused on innovation, quality, and continuous improvement.
• Access career development opportunities in a truly global organisation.