Specialist, Quality Assurance
Gilead Sciences · Tokyo, Japan
QualityFull-timeCompany career page
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What they're looking for
- Bachelor's degree in biology, engineering, or related field
- Minimum 2 years progressive quality systems experience in medical, pharmaceutical, or biologics
- Knowledge of cGMP principles and Japanese regulatory requirements
- Proficiency reading and writing English
- Experience with product import, deviation, and change control management
- Strong Microsoft Office and web-based system proficiency
- Excellent written and verbal communication skills
What you'll be doing
- Monitor quality of cell therapy product importation into Japan and manage lot disposition
- Maintain and update local quality management systems to comply with PMDA regulations
- Oversee deviations, change controls, and product complaint investigations for cell therapy products
- Interface with manufacturing sites in Japan and overseas to resolve quality issues and performance problems
- Lead or support product complaints, deviations, recalls, and field corrective actions with regulatory reporting
Privacy & handoff
This role links to Gilead Sciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.