The Opportunity:

Derived from the expression 'securing health for all of us', Seqirus has public health protection at its core. As a global leader in influenza protection, Seqirus has one of the broadest influenza vaccine portfolios in the world. In the Asia Pacific region we also manufacture and distribute a range of uniquely Australian products under contract with the Australian Government, Products of National Significance (PNS) which includes anti-venoms and Q-Fever vaccine. We also market a range of in-licensed vaccines and pharmaceuticals in Australia and New Zealand.

We are looking for an experienced Quality Control (QC) Manager to join the QC team in Parkville (Australia) on a fixed term basis until 30 June 2026. You will lead and manage a team to ensure that all activities, tests and associated services satisfy relevant regulatory, quality and customer requirements relating to Products of National Significance (PNS) and Non-Influenza Products (Non-IVV) . This will include overseeing biological potency, virology and biochemistry testing, handling small animals used in potency assays, preparing submissions for the Animal Ethics Committee (AEC) and ensuring QC compliance to GMP (Good Manufacturing Practice) and regulatory requirements including TGA (Therapeutic Goods Administration), DAFF (Department of Agriculture Fisheries and Forestry), OGTR (Office of Gene Technology Regulator) and CSL Quality Management Systems (QMS).

Reporting to the Site Head, Quality Control and working on-site, you will:

• Manage departmental resources to ensure test results are generated in compliance with approved procedures and are available on time and in full
• Manage the review, maintenance and completion of quality records and documentation to ensure integrity of information
• Manage, measure, review and report department performance against business operations plans and budgets including capital expenditure
• Maintain a strategic focus on activities in the one-month to one-year time frame
• Identify new technologies or improve existing test methods and ensure QC assays are reviewed and validated/revalidated
• Help align global QC processes and participate in global QC forums
• Select and lead staff within the department for career development and succession planning;
• Maintain good working relationships with regulatory industry bodies (auditors), main suppliers and internal/external customers;

To be considered for the role, you have:

• A tertiary qualification in Biological Sciences or equivalent;
• Minimum 7 years experience in a pharmaceutical GMP/GLP environment managing a quality team to meet business timelines;
• 3+ years experience with biological potency testing, virology and biochemistry assays
• Experience in a similar role managing a high volume of testing while meeting quality requirements;
• Experience with the application of AEC guidelines;
• Experience developing detailed budgets and plans;
• Experience in a role requiring collaboration and interaction with regulatory bodies.

How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above. Applications close by 20 August 2024.

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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 Limited (ASX: 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. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.

We want CSL Seqirus 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 Seqirus.

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