Validation Manager

1 week ago


Parkville, Victoria, Australia Seqirus A CSL Company Full time
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

  • Parkville, Victoria, Australia CSL Full time

    The 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...


  • Parkville, Victoria, Australia CSL Seqirus Full time

    The 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...


  • Parkville, Victoria, Australia CSL Full time

    The 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...


  • Parkville, Victoria, Australia 3085 Seqirus Pty Full time

    The 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...


  • Parkville, Victoria, Australia Seqirus A CSL Company Full time

    The 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...


  • Parkville, Victoria, 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 deliver fully...


  • Parkville, Victoria, Australia CSL Full time

    The Opportunity We are looking for an experienced Quality Manager to join the CSL Digital Quality team on an ongoing basis. Reporting to the Digital Quality R&D Systems Lead you will ensure compliance with GxP regulatory requirements and company policies throughout the lifecycle of computerised systems for the APAC region. You will also be the Subject...


  • Parkville, Victoria, Australia 3065 CSL Innovation Full time

    The OpportunityWe are looking for an experienced Quality Manager to join the CSL Digital Quality team on an ongoing basis. Reporting to the Digital Quality R&D Systems Lead you will ensure compliance with GxP regulatory requirements and company policies throughout the lifecycle of computerised systems for the APAC region. You will also be the Subject Matter...

  • Eresearch Manager

    1 week ago


    Parkville, Victoria, Australia Murdoch Childrens Research Institute Full time

    2 year Contract position (potential to be permanent) within Australia's largest child health research InstituteAttractive Salary + Super + Salary Packaging BenefitsBring your exceptional Data and Management skills to a team passionate about making a differenceWho We AreAt Murdoch Children's Research Institute, we share a powerful vision; to re-imagine the...


  • Parkville, Victoria, Australia University of Melbourne Full time

    Job no:Location:ParkvilleRole type:Part-time (0.4 FTE); Fixed-term until 30th June 2025Faculty:Faculty of Medicine, Dentistry and Health SciencesDepartment/School:Melbourne Medical School, Department of PaediatricsSalary:Level C.- C.3 - $135,032 to $143,300 (pro rata for part-time) p.a. plus 17% superThe University of Melbourne would like to acknowledge and...


  • Parkville, Victoria, Australia Monash University Full time

    The OpportunityThe Neuromedicines Discovery Centre (NDC) is seeking to appoint a highly motivated General Manager, Strategic Partnerships and Operations who will drive the operational business strategy of NDC through their industry knowledge and proven collaborative networks internationally. The General Manager will play a central leadership role in...

  • Development Manager

    1 week ago


    Parkville, Victoria, Australia University of Melbourne Full time

    About the Role Shape the future The Development Team tackles strategic challenges, from land use to environmental impact, driving successful real estate projects across the organisation. As the Development Manager, you will be on the forefront of collaborating and navigating projects, particularly in the front end from concept toward completion, ensuring...


  • Parkville, Victoria, Australia University of Melbourne Full time

    About the Role Reporting to the Director – Deanery Operations, the Deanery Administration Manager is a senior role critical to the smooth functioning of the MDHS Deanery. You will lead an administration team of approximately 8 Executive Assistants and administrative staff, fostering a collaborative environment and ensuring streamlined best practices....


  • Parkville, Victoria, Australia University of Melbourne Full time

    About the Role The Department of Infectious Diseases at the Peter Doherty Institute for Infection and Immunity is seeking a Research Manager for the Vaccine Research Group. The role involves managing diverse vaccine studies across all age groups in accordance with Good Clinical Practice (GCP) guidelines, with a high degree of autonomy in operational...


  • Parkville, Victoria, Australia Murdoch Childrens Research Institute Full time

    Work in Parkville in the Royal Children's HospitalCompetitive salary + super12-month part time contract (22.8 hours per week)What's in it for you?Make a difference within Australia's largest child health research instituteMaximise your pay through salary packaging including entertainment and novated leasesFlexible working options with ongoing career...


  • Parkville, Victoria, Australia Trinity College, The University of Melbourne Full time

    About UsTrinity College is a vibrant, diverse community, inspiring and enabling students of exceptional promise from Australia and around the world in its various educational programs, including a Residential College, a Theological School and a Pathways School. Trinity offers a warm collegiate workplace set amongst the leafy environs and historic buildings...


  • Parkville, Victoria, Australia University of Melbourne Full time

    About the Role Join our dynamic undergraduate admissions team, where you'll play a pivotal role in shaping the future of our university As the Undergraduate Admissions Manager, you'll oversee the seamless processing of international applications directly and domestic applications through the Victorian Tertiary Admissions Centre (VTAC). Your leadership...


  • Parkville, Victoria, Australia CSL Full time

    The Opportunity CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. We are currently recruiting for a Facility Support Services Manager to join Building Operations & Services team at our Melbourne...


  • Parkville, Victoria, Australia University of Melbourne Full time

    About the Role The ScreenED project, funded by the Medical Research Future Fund Million Minds Mental Health Research scheme, seeks a post-doctoral researcher or experienced project manager. This role will manage and coordinate efforts to develop a screening tool for detecting childhood eating disorders, involving collaboration with stakeholders across...

  • Product Manager

    1 week ago


    Parkville, Victoria, Australia University of Melbourne Full time

    Job no:Location:ParkvilleRole type:Full time / ContinuingDepartment/School:Business ServicesSalary:Senior Manager 1 ; circa 200k package incl. 17% super Expand your portfolio by joining Australia's leading university Take the major part in designing and delivering of platform solutions across the university Leading a highperforming and passionate Product...