Manager Site Compliance

Job Description

The Opportunity

An exciting opportunity has become available for a Site Compliance Manager to join the Site Compliance team in Parkville (Australia) for a fixed term of 24 months until December 31, 2025. Reporting to the Head of Site Compliance, you will support the site and related functions to ensure compliance with GxP regulations. Specifically you will prepare data and support cGMP compliance improvement programs and the implementation of industry best practice for associated Quality Systems.

The Role

Working closely with key site leaders, in this role you will:

• Coordinate Global and Site Quality Management Review including quality functional reviews;

• Coordinate the tracking of PQRs/APQRs adherence to schedule and completion

• Analyze GxP trends and other compliance related metrics;

• Collaborate with the Quality Systems team to help present site metrics;

• Partner with the site functions to reduce out of compliance events and identify potential process improvements;

• Help implement risk-based global action plans;

• Assess and communicate any changes in regulatory trends by staying up-to-date with local and global regulations;

• Manage the review process for implementing any changes to regulations;

• Manage the Regulatory Intelligence (RI) approach to provide regular updates to the business.

• Support Health Authority Inspections and responses;

Skills and Experience

To be considered for this role you have:

• Bachelor’s degree or equivalent education in a related scientific, business, process/industrial engineering role;

• 5 or more years’ experience within pharmaceutical quality systems or quality assurance;

• Experience in a role requiring critical interpretation of results;

• Proficiency in regulatory requirements including PIC/s, CFR 21, FDA and TGA and the potential impact of such regulations;

• Excellent knowledge of GMP Policies and standards and industry expectations regarding quality management system process and associated systems;

• Experience in a role requiring planning and collaboration and across different functions to achieve outcomes

• Experience in a role requiring attention to detail and strategic thinking.

How to apply:

Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-222323 by 15 January, 2024.

About Us

Our Benefits

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 Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.