The Opportunity:

We have an exciting opportunity available for an R&D Senior Quality Advisor to join our team, based at our state-of-the-art facility in Melbourne. Reporting into the R&D Quality Compliance Manager, you will ensure compliance to GMP/GSP or other GxP requirements. As the R&D Senior Quality Advisor, you will ensure relevant deviations and out of specifications are investigated; appropriate corrective and preventative actions are implemented; facilitate change controls and ensure risks are assessed and avoided. Additionally, you may review batch documentation for R&D pre-clinical and clinical product batch release to meet the R&D product release timelines for use in clinical studies.

Responsibilities:

• Quality Lead for Product Development Expert Team (PDET) meetings, provide quality/compliance leadership and oversight. Provide Quality guidance on the principles of new product introduction process
• Manage and facilitate deviation process, assess and approve deviations and OOS investigations to closure including assigned CAPA
• Facilitate the change management process, lead change panel meetings, including significant and complex changes ensuring changes are appropriate and comply with regulatory requirements.
• Manage and facilitate Product Technical Complaints and associated investigations.
• Review and Approve Documentation; not limited to SOP, WI, plans, reports, training material.
• Provide QA compliance review and approval of validation related documents and major projects.   
• Provide and assess KPI data for Local, Global and Executive Quality Management Review. Attend Local QMR, where required.     
• Conduct self inspections for GMP and GSP, provide reports in a timely manner, assess CAPA to maintain regulatory compliance and continuous improvement
• Participate in Internal Audit and Regulatory Inspections readiness    
• Participate and /or facilitate Quality Risk Assessments (QRAs) as required
• Liaise with R&D departments for quality assurance and compliance related issues. Participate and provide quality advice in market meetings for relevant R&D department
• Educate R&D staff in GxP and quality system requirements. Provide training in QMS principles and modules
• Establish and maintain local and global product related Quality Agreements

Experience Required:

• A degree in a relevant biological science, with at least 5 year’s experience in at least one of: manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant process development
• In-depth understanding of GMP requirements including Annex 13 in the pharmaceutical industry and previous production, Quality or R&D experience in the pharmaceutical industry
• Relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL
• Understanding of the product development process and auditing skills is desirable

At CSL, we're driven by our promise to patients and human health. We're also driven by our promise to employees, which is Promising Futures – our commitment to helping you fulfill your career aspirations and potential. You're our greatest asset and you help drive CSL's superior performance. We're committed to providing:

• A workplace that's respectful of your professional and personal lives — and inclusive, so you feel comfortable bringing your whole self to work.
• Total rewards that include a competitive compensation package, comprehensive benefits, and multi-dimensional wellbeing programs and recognition programs, all of which support your physical, emotional, financial, and social health and wellbeing.
• Career, performance and development programs that enable success in your current position and foster your development and growth.

If you are looking to join a purpose-driven, values-based organisation committed to protecting public health, apply now!

Applications Close on 17 November 2024

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.

Do work that matters at CSL!