Quality Assurance Manager

Koto City Tokyo CSL Behring


  • To Perform routine quality related activities (product release, deviation and internal complaint handling, CAPA, change control, GMP oversight and product recall) in compliance with global quality policies and local regulatory requirements
  • To Collaborate with internal stakeholders; Global Quality Assurance: to introduce global policy standards, Global Manufacturing Sites: to solve quality related issues and make ensure stable supply without significant quality / regulatory issues, Regulatory Affairs: to establish and implement the submission strategy, Logistics and Supply Planning: to make ensure stable supply without significant quality / regulatory issues, Sales and Marketing: to support stable commercial operations
  • To Communicate with Local Health Authorities (MHLW, PMDA, NIID and TMG) and external parties (Japan 3PL and external laboratories)
  • To Contribute to develop talent and skill in whole team
  • To Establish simplified and standardized governance model in accordance with the global policy
  • To Oversee projects (new product launch and packaging improvement)

  • Bachelor degree or equivalent degree holder, such as chemical, biochemical or pharmacy (preferable)
  • Advanced level in English (to routinely communicate with global sites, and sometimes mutually agree with the strategies)
  • Experiences in GxP (preferable; GMP and GQP) fields within pharmaceutical industry (GMP experience is not mandatory, but critical for this position since this position will have to mutually communicate with global manufacturing sites and Japan 3PL in order to make ensure stable supply with good quality)
  • Ownership mind
  • Good interpersonal skills (Collaboration, Reliability, Leadership, Positivity, Negotiation, Teamwork, Innovation and Transparency)
  • Foster engaged and inclusive culture

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 Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

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

Do work that matters at CSL Behring!

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