The Opportunity

Derived from the expression 'securing health for all of us', Seqirus has public health protection at its core. As a global leader in influenza protection, Seqirus has one of the broadest influenza vaccine portfolios in the world. In Asia Pacific we also manufacture and distribute a range of uniquely Australian products under contract with the Australian Government and market a range of in-licensed vaccines and pharmaceuticals in Australia and New Zealand.

Based in Parkville (Australia) and reporting to the Site Quality Head, we are looking for a Director Front Line Quality Assurance (QA) to join us on a permanent basis. You will lead the Front Line QA function, which is responsible for the quality of all products manufactured, sponsored and/or distributed by Seqirus Parkville following relevant regulatory and company requirements and customer expectations. You will provide manufacturing oversight, support deviation management, corrective and preventative actions (CAPA), change control and sterility assurance and oversee complaints and other post-market enquiries, recalls and actions. A key member of the Parkville Quality Leadership Team, you will support operational excellence and promote a quality culture.

The Role

In this high profile role you will:

• Set and promote the strategic direction to achieve operational compliance for all product areas of the business, promote the achievement of Quality performance expectations through leadership of direct reports, use of quality management system (QMS) / pharmaceutical quality system (PQS) elements and staff development to monitor cGMP regulated processes throughout the business;
• Ensure all function-related systems comply with all relevant regulatory bodies in all target markets with focus on TGA and FDA;
• Provide leadership to the quality organization which includes defining quality responsibilities for functions and promoting a quality culture throughout the business;
• Build relationships with regulatory authorities and lead internal and external audits;
• Collaborate with colleagues locally and globally to ensure smooth quality processes, quality system evolution, including procedural currency and harmony and encourage continuous improvement activities;
• Manage resource requirements for the Front Line QA function including training and coaching to ensure effective QA oversight and optimal productivity as well professional development;
• Maintain a safe work environment for employees in compliance with CSL policies, procedures and statutory obligations.

Your skills and experience

To be considered for this role you have:

• Post graduate qualifications in science, pharmacy, chemical engineering or similar and ideally postgraduate business or management qualifications;
• 10+ years' experience in the pharmaceutical, biotechnology or related industry with GMP requirements;
• Knowledge of Regulatory Standards (TGA, FDA and ISO-13485) and experience working with regulators including working knowledge of regulatory expectations;
• Experience with Quality Risk Management, Quality Control and Quality Assurance systems including an excellent working knowledge of GMP requirements;
• Experience making objective decisions based on risk management principles and communicating the sound justification behind them;
• Knowledge of operational processes throughout the value chain and the commercial environment;
• Experience collaborating across functional units and with global teams;
• Experience managing change and implementing a continuous improvement mindset;
• Experience in a role motivating and developing people to achieve outcomes.

How to apply: Please send us your resume and cover letter (in one document), which addresses the criteria above and includes reference number R-183737 by September 30, 2022.

Our Benefits

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

About CSL

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. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL .

We want CSL 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.

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