Engineering Quality Associate Manager, Biologics

Roche

Unknown
Csv and data integrity management
Commissioning and qualification expertise
Good manufacturing practices compliance
At Roche you can show up as yourself, embraced for the unique qualities you bring

Job Summary

  • At Roche you can show up as yourself, embraced for the unique qualities you bring.
  • This role ensures all CSV, Data Integrity and validation activities for a new large molecule drug product facility project are executed on time and in compliance with regulations.
  • The position requires leadership to create a motivated team environment, promote safety culture, and drive continuous improvement.

Matching Summary

At Roche you can show up as yourself, embraced for the unique qualities you bring.

Skills & Requirements

Must-have

  • CSV and Data Integrity management
  • Commissioning and qualification expertise
  • Good Manufacturing Practices compliance
  • Aseptic filling experience
  • Project and people management
  • Risk-based validation approaches

Nice-to-have

  • Leadership and team motivation
  • Cross-functional collaboration
  • Continuous improvement culture
  • Experience in greenfield facility projects
  • Strong communication and influence skills

Key Requirements

  • 10+ years bio-pharma industry experience
  • 5+ years people or project management
  • Bachelor’s degree in relevant science or engineering
  • Fluent English communication skills
  • In-depth knowledge of GMP and regulatory standards
  • Experience with qualification/validation lifecycle
  • Experience in aseptic filling and new DP facility projects

Work Rights

Not specified

Tailored Resume

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