(sr.) Specialist, Qs & Compliance, Biologics

Roche

Unknown
Quality management system implementation
Inspection readiness program execution
Cgmp manufacturing operations support
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.
  • The role supports the development and oversight of robust quality systems and facilitates training on GMP and Quality Compliance programs.
  • Roche empowers each other to explore new possibilities, foster creativity, and keep ambitions high to deliver life-changing healthcare solutions globally.

Matching Summary

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

Skills & Requirements

Must-have

  • Quality Management System implementation
  • Inspection Readiness program execution
  • cGMP manufacturing operations support
  • Data Integrity (ALCOA+) compliance
  • Aseptic Filling experience
  • FDA/EU cGMP knowledge

Nice-to-have

  • Project management skills
  • Technical writing experience
  • Risk-based QA decision making
  • Training facilitation on GMP compliance
  • Cross-functional collaboration

Key Requirements

  • Degree in pharmaceutical sciences or related discipline
  • Minimum 2 years pharmaceutical/biotech QA experience
  • Experience with self-inspections and multinational companies
  • Experience in new DP facility projects
  • Fluent English communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter