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CSL

Quality Process Lead APAC

Posted 3 Days Ago
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Remote
Hiring Remotely in Australia
Senior level
Remote
Hiring Remotely in Australia
Senior level
Lead and standardise APAC quality processes and electronic quality systems (SAP QM, EBR, SAP MII, RPA, Power BI). Support product launches, CMO onboarding, reporting solutions and affiliate/3PL changes. Partner with regional/global stakeholders and IT for testing, issue resolution, governance, SOPs, training, KPI-driven continuous improvement and change management in a GxP-regulated biopharma manufacturing environment.
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CSL Behring is a leading global biotechnology company driven by its promise to save lives. With manufacturing operations across multiple sites worldwide, the company relies on robust, harmonised business processes to ensure the highest quality standards.

Within the Business Process Organisation, we are seeking a Quality Process Lead for the Asia-Pacific (APAC) region. This role is responsible for the electronic quality systems and associated business processes supporting the Quality organization at the Australian manufacturing sites as well as regional affiliates across APAC.

Your Role & Responsibilities

  • Lead and improve APAC Quality processes using SAP QM, EBR, Power BI, SAP MII, and RPA, ensuring compliance with global and regulatory standards

  • Standardise and govern Quality processes across APAC in collaboration with global and site Quality leaders

  • Support key business initiatives including new product launches, CMO onboarding, reporting solutions, and affiliate or 3PL changes

  • Partner with regional and global stakeholders to improve process efficiency, resolve issues, and align priorities

  • Act as the main contact for APAC sites for process support, system testing, issue resolution, and governance activities with IT teams

  • Drive continuous improvement through analytics, KPIs, data insights, and digital Quality initiatives

  • Build strong networks with SMEs and functional leaders to support process performance, user adoption, and change management

  • Develop and maintain SOPs and training materials to support compliance and business needs

Your Skills & Experience

  • Bachelor’s or master's degree in Quality Management, Engineering, Life Sciences or related field. MBA a plus

  • 5 to 10 years of experience in Quality Management, Supply Chain Management Operations or related field. Experience within pharmaceutical or regulated industry preferred

  • 3+ years' experience with ERP. SAP proficiency is strongly preferred

  • Experience with reporting systems (e.g. SAP QM, MS PowerPlatform)

  • Excellent knowledge of quality processes including integration with planning- and execution systems

  • Agile mindset

  • Knowledge of pharmaceutical / biological manufacturing, GxP and regulatory standards, and environments

  • Experience with setting up paginated reports and dashboards within PowerBI is a plus

Location: Broadmeadows, Melbourne

Hybrid working, 3 days in the office

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

 

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.


You Belong at CSL

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.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

 

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

CSL North Sydney, New South Wales, AUS Office

5/32 Walker St, North Sydney, NSW, Australia, 2060

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