Manager, CMO Quality

CSL Limited; City of Melbourne; Hybrid; AUD 180,000 - 240,000; Full time

Job summary

CSL Seqirus is seeking an experienced quality professional to join the Global External Quality team as Manager, CMO Quality. You will provide quality oversight of CMOs and outsourced manufacturing across a global network, ensuring compliance with global standards and supporting technology transfer and lifecycle activities.

This hybrid role is based at Melbourne's Tullamarine site with occasional travel. You will partner with Quality, Supply Chain, Regulatory Affairs and Manufacturing to deliver

Qualifications

• Bachelor degree in a relevant science or quality discipline and a minimum of 5 years in a GxP-regulated pharma/biotech environment.
• Strong knowledge of global quality and regulatory requirements (FDA, PIC/S, EU, TGA).
• Experience leading deviations, CAPAs, change controls, investigations and quality systems.
• Proven ability to operate in a complex global matrix with strong stakeholder management.
• Excellent communication, negotiation and influencing skills.

Responsibilities

• Act as primary quality representative and point of contact for assigned CMOs.
• Develop, maintain and oversee Quality Agreements with external partners.
• Provide quality oversight for api, fill-finish, packaging and related ops.
• Review deviations, investigations, CAPAs, change controls and quality records.
• Monitor CMO quality performance via KPI tracking and trend analysis.
• Lead quality discussions in operational meetings and cross-functional projects.
• Support technology transfers, commercial readiness, launches and lifecycle activities.
• Facilitate issue resolution and escalation of critical quality concerns.
• Support regulatory inspections and responses for CSL Seqirus products at CMOs.
• Drive standardization and continuous improvement across external quality systems.

Skills

GxP compliance

Regulatory knowledge

Quality systems

Stakeholder management

Change controls

CAPA investigations

Deviations management

Leadership & influence

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

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.

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus