CSL is a leading biotechnology company with a dynamic portfolio of life‐saving medicines and influenza vaccines.
We are recruiting a Quality Manager, Quality IT for 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 safeguards the integrity, reliability, and compliance of computerised systems used in pharmaceutical manufacturing.
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 computerised systems and infrastructure.
* Audit & Inspection Support: Participate in internal audits of computerised 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.
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.
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