Digital Quality Manager
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.
#LI-Onsite
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
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.
We want CSL Seqirus to reflect the world around us
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. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Seqirus!
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.
#LI-Onsite
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
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.
We want CSL Seqirus to reflect the world around us
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. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Seqirus!
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