Quality Operations Lead
Lead Consulting Group Tokyo, Japan
- Posted on
- Oct 11, 2021
- Job type
- Full-time
- Career level
- Mid career
- Industry
- Pharmaceutical
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Job Description
Quality Operations Lead
This position is critical to ensure sustainable compliance of biological and vaccine products, processes, and systems with our Company’s requirements and regulatory requirements.
He/she will perform quality oversight on biological and vaccine testing and packaging operations.
- Batch record review and Release biological and vaccine products
- Preparation and review of documentation related to biologics and vaccine operations related to external testing facilities
- Perform and review investigations related to analytical testing and packaging quality issues
- Perform and review corrective and preventive actions (CAPA), change control, etc
- Perform improvement activities at biological and vaccine operations in quality
- Be a counterpart for site quality with local/global manufacturing sites
Skills (include specific skill levels required to apply our Company's Leadership Principles)
- Degree in Life Sciences, Pharmacology, or Science.
- Minimum of 3 years experience in the regulated pharmaceutical environment; preferably in a manufacturing site in quality (including QC) and/or manufacturing roles.
- Knowledge of biochemistry, testing knowledge on biological products
- Knowledgeable of Industry Best Practices for quality and compliance-related topics.
- Strong collaboration and cross-functional leadership skills to drive continuous improvements
- Preferably have project management skills.
- Preferable to have English language skills.
- Skills
- process improvement, operations, quality control
- Education level
- Bachelor's Degree
- Japanese Level
- Native/Fluent
- English Level
- Business Level
- Annual Income
- ¥6M - 10M
Location
Tokyo, Japan
English and Japanese
70% to 30%
Friendly
We offer work life balance
Lead Consulting Group
Pharmaceutical
Tokyo, Japan
About Us
Lead Consulting Group is an executive recruitment consultancy company based in Japan.We work closely with multinationals, midsize to small companies, governments, and educational institutions in the areas of human capital management and related services.