Senior Specialist, QC Operational Support
The Opportunity:
CSL Seqirus is a global leader in influenza vaccines. We are dedicated to protecting public health through cutting-edge technologies and a steadfast commitment to excellence.
We are looking for an experienced Senior Specialist, QC Operational Support to join our Global Quality Control team at our Tullamarine site. Reporting to the Senior Manager, QC Operational Support, you will manage end-to-end campaign activities within our quality control laboratories. You will oversee project management for product specifications, Contract Lab Organizations (CLOs), and Campaign Continuous Improvement (CCI).
Responsibilities:
- Product Specification Management: Ensure alignment of product specifications across all product lines, support regulatory submissions, and collaborate with key stakeholders.
- Campaign Management: Manage QC campaign activities for seasonal products, support commercial readiness, and act as the QC point of contact for regulatory activities.
- Campaign Continuous Improvement (CCI): Collaborate with QC leaders to identify and implement efficiency improvements, organize CCI workshops, and track project milestones.
- Contract Lab Management: Coordinate relationships with CLOs, manage sample testing activities, and ensure compliance with quality policies and cGMP requirements.
- Support QC Projects: Drive cost and quality enhancements, participate in knowledge-sharing efforts, and support various QC projects.
Qualifications:
- Degree in a related scientific discipline.
- 5+ years of experience in a pharmaceutical or biopharmaceutical company, with increasing responsibility in quality management.
- Experience in a highly regulated GMP environment.
- Strong project management skills and the ability to manage multi-layered projects.
- Excellent communication, presentation, and interpersonal skills.
- Strong technical writing skills and experience with QC testing methods and processes.
- Ability to think strategically and solve complex problems.
Why Join Us:
- Be part of a global leader in influenza vaccines.
- Work in a collaborative and innovative environment.
- Opportunities for professional growth and development.
- Make a meaningful impact on public health.
How to Apply:
Join us and be part of a team that is making a significant impact on global health. Please submit your application with your updated resume and cover letter outlining the key selection criteria. Applications close by 22 January 2025.
#LI-Hybrid
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.
Do work that matters at CSL Seqirus!
The Opportunity:
CSL Seqirus is a global leader in influenza vaccines. We are dedicated to protecting public health through cutting-edge technologies and a steadfast commitment to excellence.
We are looking for an experienced Senior Specialist, QC Operational Support to join our Global Quality Control team at our Tullamarine site. Reporting to the Senior Manager, QC Operational Support, you will manage end-to-end campaign activities within our quality control laboratories. You will oversee project management for product specifications, Contract Lab Organizations (CLOs), and Campaign Continuous Improvement (CCI).
Responsibilities:
- Product Specification Management: Ensure alignment of product specifications across all product lines, support regulatory submissions, and collaborate with key stakeholders.
- Campaign Management: Manage QC campaign activities for seasonal products, support commercial readiness, and act as the QC point of contact for regulatory activities.
- Campaign Continuous Improvement (CCI): Collaborate with QC leaders to identify and implement efficiency improvements, organize CCI workshops, and track project milestones.
- Contract Lab Management: Coordinate relationships with CLOs, manage sample testing activities, and ensure compliance with quality policies and cGMP requirements.
- Support QC Projects: Drive cost and quality enhancements, participate in knowledge-sharing efforts, and support various QC projects.
Qualifications:
- Degree in a related scientific discipline.
- 5+ years of experience in a pharmaceutical or biopharmaceutical company, with increasing responsibility in quality management.
- Experience in a highly regulated GMP environment.
- Strong project management skills and the ability to manage multi-layered projects.
- Excellent communication, presentation, and interpersonal skills.
- Strong technical writing skills and experience with QC testing methods and processes.
- Ability to think strategically and solve complex problems.
Why Join Us:
- Be part of a global leader in influenza vaccines.
- Work in a collaborative and innovative environment.
- Opportunities for professional growth and development.
- Make a meaningful impact on public health.
How to Apply:
Join us and be part of a team that is making a significant impact on global health. Please submit your application with your updated resume and cover letter outlining the key selection criteria. Applications close by 22 January 2025.
#LI-Hybrid
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.
Do work that matters at CSL Seqirus!
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