Manager Digital Quality R&D

4 weeks ago

Broadmeadows, Australia 3065 CSL Innovation Full time

The Opportunity

We are looking for an experienced Quality Manager to join the CSL Digital Quality team on an ongoing basis. Reporting to the Digital Quality R&D Systems Lead you will ensure compliance with GxP regulatory requirements and company policies throughout the lifecycle of computerised systems for the APAC region. You will also be the Subject Matter Expert (SME) and provide quality oversight and approval of change controls, deviations and investigations, CAPAs, and Periodic Review assessments involving GxP computerised systems.

The Role

Based primarily at CSL Melbourne but working flexibly, as the Manager Digital Quality R&D APAC you will work with local and global partners to:

  • Participate in project teams to provide review and approval of project Validation documentation according to applicable approval matrix or procedures.
  • Participate in vendor / supplier audits / assessments and qualification activities involving GxP computerized systems as an SME.
  • Participate in internal GxP audits of computerized systems as an SME.
  • Support GxP health authority inspections by serving as SME for computerized systems topics.
  • Contribute to continuous QMS improvements and/or supports the development of quality standards in the area of computerized systems.
  • Provide guidance on quality and regulatory requirements to project teams, internal partners and other teams on GxP compliance relating to computerized systems.
  • Collaborate with I&T and R&D and other relevant subject matter experts.

Your skills and experience

To be considered for this role you have:

  • Bachelor's degree or equivalent; education preferably concentrated in IT, Quality, Engineering or Science
  • 5+ years' experience in Quality, IT or Validation
  • 3+ years' experience in Pharma/Biotech or similarly regulated environment
  • 2+ years' experience in Quality Assurance, IT, Quality Control, Validation, Production, or Regulatory Affairs
  • Knowledge of GxP, GAMP, FDA and EMA requirements specifically CFR21 part11 and Annex 11
  • Experience communicating complex information accurately and effectively including writing technical documents
  • The ability to analyse data and situations to support quality decision-making
  • Experience in a role requiring initiative and independent work
  • The ability to communicate and collaborate with partners and key stakeholders at all levels and across the organisation to influence outcomes.

Please note: This role may require up to 10% travel

How to apply

Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-232991 by 5 June May 2024.

#LI-Hybrid

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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