Key skills
Communication
About this role
Role Overview
- Provide quality oversight and technical expertise for enterprise systems and CGT-specific applications
- Collaborate with global cross-functional teams to maintain regulatory compliance
- Develop and implement a data integrity program
- Directly support internal and external audits and oversee quality records
Requirements
- Bachelor’s or Post-Graduate degree in Science, Engineering, or a related field
- At least 10 years of quality experience in the pharmaceutical or biotech industry
- Deep expertise in Cell & Gene Therapy (CGT)
- Profound understanding of GxPs, FDA/EMA regulations, and global data integrity requirements
- Exceptional communication and influencing skills
- Ability to manage multiple priorities and travel internationally for work.