CSL is a leading biotechnology company with a dynamic portfolio of life-saving medicines as well as vaccines to prevent influenza.
We are recruiting a Quality Manager, Quality IT to join our team at our state of the art, manufacturing facility at 2 Sky Rd, Melbourne Airport VIC 3045.
Description of the role
The IT Quality Manager ensures that GxP-relevant IT systems and infrastructure - including both hardware and software - are implemented, maintained, and operated in compliance with internal and external Computer Systems Validation (CSV) standards and regulatory guidelines.
This role is critical in safeguarding the integrity, reliability, and compliance of computerised systems used in pharmaceutical manufacturing.
This is a Permanent full-time position.
Key Responsibilities:
Validation Oversight: Participate in cross-functional project teams to review and approve validation and qualification documentation following established procedures and approval matrices.
Quality Governance: Act as a subject matter expert (SME) providing quality oversight and approval for change controls, deviations, investigations, and periodic reviews related to GxP computerized systems and infrastructure.
Audit & Inspection Support: Participate in internal audits of computerized systems and support health authority inspections by serving as an SME for digital quality and CSV-related topics.
Continuous Improvement: Lead and contribute to the ongoing enhancement of the Quality Management System (QMS), particularly in areas related to digital compliance and CSV.
Stakeholder Engagement: Foster strong relationships with key stakeholders across Information & Technology (I&T), business units, and subject matter experts to ensure alignment and compliance in digital initiatives.
Qualifications and Experience required:
Proven experience in Computerised Systems Validations (CSV) and digital quality within a regulated pharmaceutical or biotech environment.
Strong understanding of GxP, cGMP, and regulatory frameworks.
Demonstrated ability to manage complex projects and foster collaborative relationships.
Experience in audit readiness, data integrity, and IT vendor qualification.
University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Application Period: Applications open on 25 February 2026 and close on 26 March 2026.
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
