Compliance Manager

4 days ago

Parkville, Australia Seqirus Full time

**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.**:

- **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**:
**Watch our ‘On the Front Line’ video to learn more about CSL Seqirus

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