Validation Manager
2 months ago
The Opportunity
CSL Seqirus, part of the CSL family, manufactures Products of National Significance (PNS) and Other Non-IVV (non-influenza) including anti-venoms, anti-toxins and Q-fever vaccinations. We are focused on saving lives all around the world through innovation and global collaboration.
We are looking for an experienced Validation Manager to join the great team at Parkville (Australia). This is a full-time, permanent or fixed term position (depending on your current employment status), where you will lead a small team to perform all aspects of quality validation to support changes to existing plant, equipment and processes for the Seqirus Australia business. You will also manage the delivery of the project validation requirements.
The Role
Reporting to the Senior Manager Validation and based on-site in Parkville (Australia), you will:
- Manage the preparation, review, implementation and maintenance of departmental documentation for all validation activities and regulatory submissions (i.e. Validation protocols and reports, Executive Summaries and Validation Master Files);- Promote the education and implementation of the requirements of the current TGA Code of Good Manufacturing Practice, US Code of Federal Regulations and other guidelines;- Manage the participation of the team in internal and external audits;- Provide leadership to the validation team to ensure performance is following the Business Plan and the Quality Management System and compliant with all codes, regulations and Seqirus policies.- Lead, coordinate and coach the team members including managing their development and performance appraisal;- Identify opportunities for improvement to optimise validation activities;- Measure and review the performance of projects against plans and provide regular updates on progress, resource issues and timelines to Quality Management.
Your skills and experience
To be considered for this role, you have:
- A degree in Science or Engineering;-
- 6+ years' experience with pharmaceutical industry guidance documents and standards including PICs;- 4+ years' experience leading a technical team in a regulated environment;- Experience in the pharmaceutical manufacturing industry;- Experience with statistical analysis software;- Experience in a role solving complex problems and collaborating across different departments;- Experience in a role requiring the completion of a range of different activities within timelines;- Experience presenting complex information both in writing and verbally.
How to Apply:
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
We have other current jobs related to this field that you can find below
-
Validation Manager
1 week ago
Parkville, Victoria, Australia Seqirus A CSL Company Full timeThe OpportunityCSL Seqirus, part of the CSL family, manufactures Products of National Significance (PNS) and Other Non-IVV (non-influenza) including anti-venoms, anti-toxins and Q-fever vaccinations. We are focused on saving lives all around the world through innovation and global collaboration.We are looking for an experienced Validation Manager to join the...
-
Validation Associate
1 week ago
Parkville, Victoria, Australia CSL Full timeThe Opportunity Derived from the expression 'securing health for all of us', CSL Seqirus is a global leader in influenza protection. In Asia Pacific we also manufacture and distribute a range of uniquely Australian products market a range of in-licensed vaccines and pharmaceuticals in Australia and New Zealand. We are looking for a Validation Associate...
-
Validation Associate
1 week ago
Parkville, Victoria, Australia CSL Seqirus Full timeThe OpportunityDerived from the expression 'securing health for all of us', CSL Seqirus is a global leader in influenza protection. In Asia Pacific we also manufacture and distribute a range of uniquely Australian products market a range of in-licensed vaccines and pharmaceuticals in Australia and New Zealand.We are looking for a Validation Associate to join...
-
Validation Associate
4 weeks ago
Parkville, Australia 3085 Seqirus Pty Full timeThe OpportunityDerived from the expression 'securing health for all of us', CSL Seqirus is a global leader in influenza protection. In Asia Pacific we also manufacture and distribute a range of uniquely Australian products market a range of in-licensed vaccines and pharmaceuticals in Australia and New Zealand.We are looking for a Validation Associate to join...
-
Validation Specialist
2 weeks ago
Parkville, Australia Seqirus Full time**The Opportunity**: Located in Parkville (Australia) and part of the Analytical Sciences and Technology (AS&T) Department a **12 month fixed term contract** opportunity has become available for a **Validation** **Specialist** to participate in the validation and implementation of scientific methods and technologies into the Quality Control...
-
Validation Specialist
2 weeks ago
Parkville, Australia Seqirus A CSL Company Full timeThe Opportunity Located in Parkville (Australia) and part of the Analytical Sciences and Technology (AS&T) Department a 12 month fixed term contract opportunity has become available for a Validation Specialist to participate in the validation and implementation of scientific methods and technologies into the Quality Control laboratories. The...
-
Senior Validation Associate
1 month ago
Parkville, Australia CSL Full timeThe Opportunity Located in Parkville (Australia), we are looking for Senior Validation Associate to join the great team at Parkville (Australia). In this fixed term full-time position, until 30 June 2026, to support the Parkville Site Exit and Decommissioning activities by generating facility decommission plans aligned with the Decomissioning Site...
-
Senior Validation Associate
3 weeks ago
Parkville, Australia CSL Full timeThe Opportunity Located in Parkville (Australia), we are looking for Senior Validation Associate to join the great team at Parkville (Australia). In this fixed term full-time position, until 30 June 2026, to support the Parkville Site Exit and Decommissioning activities by generating facility decommission plans aligned with the Decomissioning Site...
-
Senior Validation Associate
1 week ago
Parkville, Victoria, Australia CSL Full timeThe Opportunity Located in Parkville (Australia), we are looking for Senior Validation Associate to join the great team at Parkville (Australia). In this fixed term full-time position, until 30 June 2026, to support the Parkville Site Exit and Decommissioning activities by generating facility decommission plans aligned with the Decomissioning Site...
-
Senior Validation Associate
1 month ago
Parkville, Australia 3085 Seqirus Pty Full timeThe OpportunityLocated in Parkville (Australia), we are looking for Senior Validation Associate to join the great team at Parkville (Australia). In this fixed term full-time position, until 30 June 2026, to support the Parkville Site Exit and Decommissioning activities by generating facility decommission plans aligned with the Decomissioning Site Validation...
-
Senior Validation Associate
4 weeks ago
Parkville, Australia 3085 Seqirus Pty Full timeThe OpportunityLocated in Parkville (Australia), we are looking for Senior Validation Associate to join the great team at Parkville (Australia). In this fixed term full-time position, until 30 June 2026, to support the Parkville Site Exit and Decommissioning activities by generating facility decommission plans aligned with the Decomissioning Site Validation...
-
Senior Validation Associate
1 week ago
Parkville, Victoria, Australia 3085 Seqirus Pty Full timeThe OpportunityLocated in Parkville (Australia), we are looking for Senior Validation Associate to join the great team at Parkville (Australia). In this fixed term full-time position, until 30 June 2026, to support the Parkville Site Exit and Decommissioning activities by generating facility decommission plans aligned with the Decomissioning Site Validation...
-
Qc Manager
3 weeks ago
Parkville, Australia Zoetis Full timeThis position reports to the Internal Manufacturing Site Quality Lead, ANZ, and will serve as the most senior Quality Control Leader for the Site. The Site Quality Control Lead will have overall responsibility to manage and control all QC activities in accordance with identified Global Zoetis Quality Systems and Standards as well as all relevant regulatory...
-
Manager, QA Cont Imp
1 week ago
Parkville, Victoria, Australia Seqirus A CSL Company Full timeThe Opportunity Located in Parkville, Australia, the Manager Quality Assurance Frontline (QA Validation) is a fulltime ongoing or fixed term position (depending on your current employment status). You are pivotal role in raising the standards of the site, and you will work closely with Engineering, IT, Quality Control and Validation teams to deliver fully...
-
Manager, QA Cont Imp
2 months ago
Parkville, Australia Seqirus A CSL Company Full timeThe Opportunity - Located in Parkville, Australia, the Manager Quality Assurance Frontline (QA Validation) is a full-time ongoing or fixed term position (depending on your current employment status). You are pivotal role in raising the standards of the site, and you will work closely with Engineering, IT, Quality Control and Validation teams to deliver fully...
-
Manager, QA Cont Imp
2 months ago
Parkville, Australia Seqirus Full time**The Opportunity**: Located in Parkville, Australia, the **Manager **Quality Assurance Frontline (QA Validation)** is a full-time ongoing or fixed term position (depending on your current employment status). You are pivotal role in raising the standards of the site, and you will work closely with Engineering, IT, Quality Control and Validation teams to...
-
Manager, QA Cont Imp
1 week ago
Parkville, Victoria, Australia Seqirus Full timeThe Opportunity:Located in Parkville, Australia, the Manager Quality Assurance Frontline (QA Validation)** is a full-time ongoing or fixed term position (depending on your current employment status). You are pivotal role in raising the standards of the site, and you will work closely with Engineering, IT, Quality Control and Validation teams to deliver fully...
-
Discovery Manager
3 weeks ago
Parkville, Australia University of Melbourne Full time**Job no**: 0019540 **Location**:Parkville **Role type**:Full time; Continuing **Department/School**: Student and Scholarly Services **Salary**:UOM 9 - $129,154 - $134,374 p.a. plus 17% super - Lead a strong library systems team in implementing seamless discovery pathways to scholarly resources - Facilitate solutions to issues of access for our students and...
-
Centre Manager
2 months ago
Parkville, Australia University of Melbourne Full time**Job no**: 0059588 **Location**:Parkville **Role type**:Full-time; Continuing **Faculty**:Medicine, Dentistry and Health Sciences **Department/School**:Collaborative Practice Centre **Salary**:UOM 8 - $115,137 - $124,622 p.a. plus 17% super - **Lead and oversee activities of Australia's first Collaborative Practice Centre.**: - **Work closely with the...
-
Centre Manager
2 days ago
Parkville, Australia University of Melbourne Full time**Job no**: 0059588 **Location**:Parkville **Role type**:Full-time; Continuing **Faculty**:Medicine, Dentistry and Health Sciences **Department/School**:Collaborative Practice Centre **Salary**:UOM 8 - $115,137 - $124,622 p.a. plus 17% super - **Lead and oversee activities of Australia's first Collaborative Practice Centre.**: - **Work closely with the...
