Job Description

The Opportunity

Come and join the growing Banksia team as a Quality Control (QC) Site Lead for Woodend to support the construction of our advanced Product of National Significance (PNS) manufacturing facility in Woodend (Victoria, Australia). This is an ongoing role which will work across the Tullamarine and Woodend sites and report to the Banksia Project QC Lead during the project phase.

In this varied role you will provide technical leadership in the development and commissioning of the Quality Control (QC) laboratories for the Seqirus Woodend site inclusive of QC Equipment/Assay transfer activities, PNS/FCC Facility startup or the FIP Facility startup. You will ensure the Woodend Quality Control department complies with the cGMP legal and regulatory requirements and the Seqirus Quality Manual and is ready for operation at the end of the project in 2026.

The Role

As the QC Site Lead Woodend, you will:

• Ensure purchase and installation of equipment, as the site is established;

• Evaluate the performance of analytical instruments and equipment and ensure they are qualified and calibrated following cGMP;

• Develop and implement new methods and testing procedures and maintain standard operating procedures;

• Record quality issues and performance measures for management review;

• Ensure the QC portion of the project complies with the requirements of the Quality Manual and meets all relevant cGMP regulatory requirements;

• Develop budgets and ensure that the project operates in a cost-effective way;

• Provide daily direction for your team to maintain steady workflow and productivity;

• Collaborate with local and global teams to oversee method transfer activities to the applicable site.

Your skills and experience

To be considered for this role you have:

• A bachelor's degree in a related scientific field, advanced degree would be an advantage;

• 5+ years' experience in a GMP regulated environment or Quality Control within the pharmaceutical industry;

• A detailed understanding of the Code of Animal Ethics;

• An understanding of Regulatory Standards (TGA (PIC/S, DEDJTR), FDA (CFR) and ISO-13485), Quality Risk Management, Quality Control and Quality Assurance systems including a working knowledge of GMP requirements;

• 3+ years' experience in laboratory operations and 3+ years' experience managing a team;

• Experience working with Regulatory Agencies such as TGA, DEDJTR and FDA;

• Experience in a role requiring collaboration and project leadership;

• Experience in a role requiring the completion of a range of different activities following a schedule;

• Experience in presentation complex information both in writing and verbally.

How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above and includes the number R-217111 by 30 October, 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.

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.

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