Principal QA Information Systems Engineer at Roche ensuring quality for CGT systems compliance. Collaborating globally to implement and maintain regulatory standards in healthcare technology.
Responsibilities
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.
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