Quality Assurance Manager
- Military veterans preferred
2024-03-28 AppCast (https://www.appcast.io)
Other
/yr
full-time
employee
Koto City 135 Japan
Responsibilities:
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)
Qualifications:
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 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 .
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 at CSL.
