Senior Manager QC Microbiology
Job Type: Full time
Seqirus, part of the CSL Family, is a leader in egg-based influenza vaccine manufacturing, in-licensed vaccines and specialty pharmaceuticals, we are also the sole supplier of a unique range of products made in the national interest for the Australian Government. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats.
The CSL Seqirus Quality Control team in Parkville (Australia)is looking for an experienced Microbiology professional for an 18-month fixed term, until 31 December 2024. Reporting to the Head Quality Control, you will lead the Bacteriology, Sterility, Virology and Environmental Monitoring (EM) teams. You will also lead the alignment and site implementation of Global QC Microbiology testing processes, actively participate in Global QC Microbiology forum, and site sterility assurance improvement projects.
As the Senior Manager QC Microbiology, you will:
- Lead the Microbiology Department to ensure in process and batch release testing critical to the safety and quality of Seqirus products are conducted to support operational timelines.
- Maintain Quality Control procedures to ensure compliance with company standards, Good Manufacturing Practice (GMP) and regulatory guidelines.
- Set goals and objectives for team members to achieve operational results, manage performance, encourage a culture where employees ensure their own and others health, safety and security in the workplace and seek to minimise the environmental impact of their activities.
- Manage, measure, review and report department performance against business operations plans.
- Maintain good working relationships with relevant regulatory bodies, key suppliers and internal/external customers and collaborate to investigate deviations and implement corrective actions.
- Plan and manage departmental resources and budgets to ensure test results are generated in compliance with approved procedures and are available on time and in full.
- Actively participate in global QC Microbiology forum, global and site sterility assurance improvement initiatives.
- Lead the ongoing implementation of variability reduction projects across QC.
- Continually seek to identify new technologies or improve existing test methods for both increased precision and cost effectiveness.
Your skills and experience
To be considered for this role you have"
- Bachelor degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.); advanced degree preferred;
- 7+ years' experience in microbiological and biological analytics in a pharmaceutical/medicinal GMP environment.
- 4+ years’ experience managing and leading teams, ideally in a high throughput laboratory.
- Knowledge of QC test methods, analytical method validation, GMP and Good Laboratory Practice (GLP) and ICH Guidelines
- Experience in presenting complex scientific information in both written and verbal form
- Experience in working across a range of different disciplines to influence outcomes
- Experience working with external regulators including TGA and FDA
How to apply
Please send us your resume and cover letter (in one document), which addresses the criteria above and includes reference number R-213718 by September 22, 2023.
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.
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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