Regulatory Quality Assurance Lead

The Opportunity

We are looking for a Regulatory Quality Assurance (RQA) Lead to join the global Quality team on an ongoing basis. Based anywhere in the Asia Pacific region and working globally, you will provide oversight for the development and maintenance of sustainable and scalable, globally aligned quality processes across Global Regulatory Affairs (GRA), Global Medical Affairs (GMA), commercial and other related departments to ensure that processes comply with all relevant requirements and especially those activities that affect the Pharmacovigilance (PV) system.

The Role

Reporting to the Global Head, Regulatory Quality Assurance (RQA), you will

• Work with internal and external partners to investigate and resolve GxP non-compliance, deviations and process related issues providing recommendations for solutions
• Define and continuously assess quality/performance indicators; identification of quality issues and escalation thereof to the Global Head RQA
• Support the ongoing quality review of GxP relevant GRA/ GMA procedural documents and new/ updated GxP relevant GCSP procedural documents
• Lead quality assurance training for GRA, GMA, affiliates and other respective interfaces and communicate best practices
• Support/ perform pre-inspections and mock inspections for all Health Authority inspections which involve GVP topics as well as 3rd party audits of CSL's PV system
• Analyze audit observations, gaps, and systematic issues to help to support continuous improvement in the area of GRA, GMA and Commercial
• Support PVRQA/R&D Quality to ensure accurate reports on respective metrics, findings, and trends stemming from audits, inspections and deviations and propose and/or implement improvement initiatives
• Work with the Global Head RQA, to assure the development and implementation of a process for qualification of GRA/GMA service providers, as applicable.
• Ensure processes (including respective KPIs) are in place for quality oversight of all active service providers and maintenance of the respective qualified service provider list.

Your skills and experience

To be considered for this role you have:

• A graduate degree in Scientific Discipline/ Life Sciences or related disciplines, or alternatively a bachelor's degree and work experience as below.
• 5+ years' of pharmaceutical industry or research/management experience,
• 4+ years' experience in Regulatory Affairs, Medical Affairs, Pharmacovigilance or GxP Quality Assurance experience
• Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (GVP, GCP, etc.)
• Experience having to navigate and negotiate priorities in a global environment
• Experience in a role requiring leadership and communication with special emphasis on collaboration, influencing and negotiation across all levels within an organization
• Ability to work independently and as a team member
• Ability to think strategically and to quickly analyze complex circumstances and problems, and to guide appropriate decisions.

How to apply

Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-234287 by 21 June 2024.

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

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

Do work that matters at CSL Seqirus.

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