Compliance Manager
Your Opportunity
Join Seqirus as a Compliance Manager at our Tullamarine site, where you'll play a pivotal role in ensuring site-wide GxP compliance and regulatory readiness. Reporting to the Head of Site Compliance, you'll work closely with cross-functional teams and global stakeholders to support regulatory licensing, quality systems, and continuous improvement initiatives. This is a full-time, on-site role critical to the success of our new manufacturing facility.
Your Role
-
Lead and coordinate site compliance activities, ensuring alignment with global GxP standards and regulatory expectations (e.g., FDA, TGA, DAFF, OGTR).
-
Manage regulatory licensing and permit processes, including manufacturing licenses and import permits for specific strains and materials.
-
Monitor and interpret changes in global regulatory guidelines, assess their impact, and support implementation of necessary changes.
-
Drive internal compliance initiatives, including audit readiness, deviation management, and regulatory intelligence reporting.
-
Act as the site liaison with Global Quality Systems & Compliance, supporting global forums and quality council reviews.
-
Support and influence a culture of continuous improvement, challenging the status quo and driving innovation in compliance practices.
Your skills and experience
-
Bachelor's degree in a relevant scientific or engineering discipline (e.g., Pharmacy, Chemistry, Biology, Biotech, Process/Industrial Engineering).
-
Minimum 5 years' experience in a GxP-regulated environment, with a strong background in compliance or quality systems.
-
Demonstrated experience interpreting and applying regulatory guidelines (e.g., DAFF, OGTR, FDA, EMA, TGA) to operational practices.
-
Familiarity with regulatory licensing processes and the ability to assess and communicate the impact of regulatory changes.
-
Experience working in or with a start-up or transitioning site is highly desirable.
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
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Seqirus!
Your Opportunity
Join Seqirus as a Compliance Manager at our Tullamarine site, where you'll play a pivotal role in ensuring site-wide GxP compliance and regulatory readiness. Reporting to the Head of Site Compliance, you'll work closely with cross-functional teams and global stakeholders to support regulatory licensing, quality systems, and continuous improvement initiatives. This is a full-time, on-site role critical to the success of our new manufacturing facility.
Your Role
-
Lead and coordinate site compliance activities, ensuring alignment with global GxP standards and regulatory expectations (e.g., FDA, TGA, DAFF, OGTR).
-
Manage regulatory licensing and permit processes, including manufacturing licenses and import permits for specific strains and materials.
-
Monitor and interpret changes in global regulatory guidelines, assess their impact, and support implementation of necessary changes.
-
Drive internal compliance initiatives, including audit readiness, deviation management, and regulatory intelligence reporting.
-
Act as the site liaison with Global Quality Systems & Compliance, supporting global forums and quality council reviews.
-
Support and influence a culture of continuous improvement, challenging the status quo and driving innovation in compliance practices.
Your skills and experience
-
Bachelor's degree in a relevant scientific or engineering discipline (e.g., Pharmacy, Chemistry, Biology, Biotech, Process/Industrial Engineering).
-
Minimum 5 years' experience in a GxP-regulated environment, with a strong background in compliance or quality systems.
-
Demonstrated experience interpreting and applying regulatory guidelines (e.g., DAFF, OGTR, FDA, EMA, TGA) to operational practices.
-
Familiarity with regulatory licensing processes and the ability to assess and communicate the impact of regulatory changes.
-
Experience working in or with a start-up or transitioning site is highly desirable.
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
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Seqirus!
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