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Senior Manager Quality

CSL

Location: Parkville

Job Type: Full time

Posted


Job Description

The Opportunity

We are looking for an experienced Senior Manager to join to join our growing project Banksia team for the construction of our state-of-the-art Influenza cell-culture (FCC) manufacturing facility in Tullamarine (Victoria, Australia). Expected to be completed in 2026, this facility will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere and will also produce unique products important to Australia's public health needs such as snake and spider antivenoms.

In this full-time fixed term position, ending 30th June 2026, as the Senior Manager Quality - Banksia, you will design and implement the Quality and Change Control Plans. You will also develop and maintain the system to implement the Pharmaceutical Quality System at Tullamarine and Woodend sites.

The Role

Reporting to the Senior Director QA – Quality Assurance, you will:

  • Implement the Quality plan for Project Banksia;
  • Prepare data for Quality Governance metrics to assess and monitor actions against the Quality Plan;
  • Work with departments to ensure smooth implementation of quality processes and provide advice relating to Quality Assurance;
  • Develop, maintain and improve the Change control plan as the project progresses. Ensure all GMP applications are covered by Change control and managed to achieve for regulatory approval of the site;
  • Develop and implement the local Pharmaceutical Quality System for the Woodend and Tullamarine sites according to the Global Framework;
  • Ensure Gap assessments are complete against all elements of the Global polices, and procedures are developed and in place across the business;
  • Create Quality procedures for the Project and for the site to improve operations and compliance;
  • Work with the Banksia team to ensure the 3 PL warehouse has the required documents and systems in place;
  • Recruit and develop Quality professionals to manage the Change process as the project progresses Prepare data for Quality Governance metrics to assess and monitor actions against the Quality Plan and facilitate Risk Assessments to support the business.

Your skills and experience

To be considered for this role, you have:

  • A University degree in a science or engineering;
  • 8+ years' quality experience in pharmaceutical manufacturing/cGMP environment;
  • Experience within Quality Assurance with increasing level of responsibility;
  • Experience applying current Good Manufacturing Practices (cGMP) principles;
  • Experience with Regulatory Standards (TGA (PIC/S), FDA (CFR) and ISO-13485), Quality Risk Management, Quality Control and Quality Assurance systems;
  • Experience in a role requiring the communication of complex information including technical writing;
  • Experience in a role requiring analysis and accuracy;
  • Experience analysing complex problems and developing compliant new processes and standards;
  • Demonstrated flexibility to manage changing priorities and motivated to meet timelines.

How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-193890 by 30 January, 2023.

About Us

Our Benefits

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 Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

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

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