Your Opportunity:
We are looking for a Digital Quality Manager to join our Quality Assurance Compliance team in Tullamarine. Asa Digital Quality Manager, you will help ensure 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. You will help safeguard the integrity, reliability, and compliance of computerised systems used in pharmaceutical manufacturing.
Your Role:

Reporting to the Senior Manager, Quality Assurance Site Compliance, you will:

• 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: 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.

Your Experience:

• Proven experience in Computerized 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.

Apply Now!
Join a company that’s making a difference. Apply now with your updated resume to be part of a team that’s shaping the future of public health through digital innovation and quality excellence.

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Please refer the Job description for details