Manager Site Compliance Pharmaceutical

The Opportunity
We are looking for a Quality Assurance Manager (QA) to join our growing quality team in Tullamarine (Victoria, Australia). Expected to be completed in 2026, this facility will be the only cell-based influenza (FCC) vaccine manufacturing facility in the Southern Hemisphere and will also produce unique products important to Australia's public health needs such as snake and spider antivenoms.
Based onsite at Tullamarine and reporting to the Head of Site Compliance, in this 12 month maternity leave replacement role you will support and ensure that the site complies with GxP regulations, including, cGMPs, cGLPs and regulatory standards from the Department of Agriculture Fisheries and Forestry (DAFF) & Office of the Gene Technology (OGTR). You will work with Banksia SMEs to ensure all project timelines for DAFF and OGTR are met and help track audit performance metrics and completion of PQR/APQRs.
The Role
In this high profile role, you will:

• Co-ordinate Global and site Quality Council, including Global Operational and Quality functional reviews, support global forums and work with the quality systems team to help deliver site quality metrics.
  
• Lead and prepare for Approved Arrangements in inspections and hosting DAFF/OGTR facility inspections and work with the site Audit team, to oversee the tracking of regulatory findings and trends that may lead into a focus of regulatory inspections for DAFF and OGTR.
  
• Liaise with government regulators (DAFF/OGTR) regarding facilities, licences, inspections and approvals and support applications for OGTR Licences.
  
• Organise and host Third-party Assessors (TPAs) for all biosecurity Containment facilities and follow up and oversee, to completion, any actions arising from TPA inspections.
  
• Interpret new /changing regulations and provide impact assessments and recommendations and prepare required documentation according to DAFF / OGTR requirements.
  
• Support applications for DAFF Import permits/In vivo/End-use approvals, and update the DAFF/OGTR Internal database once Facility Certifications and Regulatory Approvals are issued.
  
• Coordinate IBC forums and support facility application for review and risk assessments related to GMOs and biosecurity.
  

Your skills and experience
To be considered for this role you have:

• A bachelor’s degree in an Engineering or Science related field.
  
• 5 years' experience within pharmaceutical quality systems / quality assurance, including Quality Management Systems and local and international Regulatory Standards, Quality Risk Management, and cGMP.
  
• Proficient in applying GxPs, DAFF, OGTR , FDA, EMEA, and TGA Regulations governing validated applications including 21CFR Part 11, in a similar or related role.
  
• Understanding of potential impact of Regulations/Trends on the business and identify global/local actions.
  
• Experience in a role requiring collaboration, reviewing technical documents and communicating complex information and writing technical documents.
  
• Experience in a role requiring data analysis, evaluation of alternatives and efficient issue resolution.
  

How to apply:
Please send us your resume and covering letter (in one document), which addresses the skills and experience above and includes reference number R-226408 by 03 March 2024.
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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.
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