Principal Qa Information Systems Engineer

healthsciencejobs.ch

Base: 136,936.00 to 179,728.50 cad; bonus/equity: ...
Not specified in the job description.
Quality oversight for cgt erp systems
Regulatory compliance with fda/ema
Data integrity program development
Roche is seeking a Principal QA Information Systems Engineer to join their Cell & Gene Therapies team, focusing on quality oversight and technical expertise for enterprise systems and CGT-specific applications. The ideal candidate will possess at least 10 years of quality experience in the pharmaceutical or biotech industry, with deep regulatory knowledge and strong collaboration skills

Job Summary

  • As a Principal QA Information Systems Engineer, you will provide critical quality oversight and technical expertise to ensure enterprise systems and CGT-specific applications are robust, compliant, and innovative.
  • You will develop, implement, and lead a comprehensive data integrity program compliant with evolving global regulatory standards and industry best practices.
  • Roche fosters a diverse and inclusive community focused on delivering personalized healthcare and pushing the boundaries of medical possibility.

Matching Summary

Match Score: 85

Roche is seeking a Principal QA Information Systems Engineer to join their Cell & Gene Therapies team, focusing on quality oversight and technical expertise for enterprise systems and CGT-specific applications. The ideal candidate will possess at least 10 years of quality experience in the pharmaceutical or biotech industry, with deep regulatory knowledge and strong collaboration skills.

Salary

Base: 136,936.00 to 179,728.50 CAD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Quality oversight for CGT ERP systems
  • Regulatory compliance with FDA/EMA
  • Data integrity program development
  • Cross-functional global collaboration
  • SAP and technical platform expertise

Nice-to-have

  • Proactive problem-solving attitude
  • Advanced negotiation and influencing skills
  • Cultural awareness and adaptability
  • Exceptional communication skills

Key Requirements

  • At least 10 years quality experience
  • Bachelor’s or Post-Graduate degree in Science or Engineering
  • Deep expertise in Cell & Gene Therapy
  • Knowledge of GxPs and global data integrity requirements
  • Experience with FDA/EMA regulations

Work Rights

Not specified

Tailored Resume

Cover Letter