Head Of Analytical Testing, Biologics

Roche

Shanghai, China
Not specified
5+ years qc experience large molecule characterization
3+ years people management experience
Bioanalytical method validation expertise
Roche is seeking a Head of Analytical Testing for its biologics division in Shanghai, China. This leadership role involves overseeing quality control processes, ensuring compliance with regulatory standards, and leading a team in the development and validation of bioanalytical methods

Job Summary

  • This role involves leading the setup of a bioanalysis laboratory that complies with regulatory requirements while managing routine product control strategies.
  • The successful candidate will ensure compliance with Chinese GMP, EU GMP, and U.S. cGMP regulations while leading team development through coaching and mentoring.
  • Roche offers a culture that encourages personal expression and genuine connections where every voice matters to prevent, stop, and cure diseases.

Matching Summary

Match Score: 85

Roche is seeking a Head of Analytical Testing for its biologics division in Shanghai, China. This leadership role involves overseeing quality control processes, ensuring compliance with regulatory standards, and leading a team in the development and validation of bioanalytical methods.

Skills & Requirements

Must-have

  • 5+ years QC experience large molecule characterization
  • 3+ years people management experience
  • Bioanalytical method validation expertise
  • Product control strategy implementation
  • GMP compliance knowledge NMPA FDA EMA

Nice-to-have

  • Experience with disposable materials inspections
  • Strategic project design and commissioning
  • Agile ways of working application
  • Fluent English communication skills
  • Global quality audit leadership

Key Requirements

  • Bachelor's Degree in Life Sciences or related field
  • Special Equipment management certification preferred
  • Hands-on experience implementing product control strategies
  • Experience with NMPA/FDA/EMA/TGA/PMDA inspections
  • QC new facility startup readiness experience

Work Rights

Not specified

Tailored Resume

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