Associate Manager, Qs & Compliance, Biologics

Roche

Shanghai, China
Not specified (likely hybrid or onsite based on the nature of the role).
7 years pharmaceutical quality experience
Aseptic filling process expertise
Fda/eu cgmp regulatory knowledge
Roche is seeking an Associate Manager for Quality and Compliance in Biologics, based in Shanghai, China. The role involves overseeing compliance with quality management systems, managing regulatory inspections, and providing guidance on quality assurance topics within the pharmaceutical sector

Job Summary

  • The role involves mobilizing new sites from a quality and compliance perspective while overseeing technical change control processes.
  • Candidates must have extensive experience managing regulatory inspections with global health authorities and representing the company effectively.
  • Roche fosters a culture of personal expression and open dialogue where every voice matters in the mission to prevent and cure diseases.

Matching Summary

Match Score: 85

Roche is seeking an Associate Manager for Quality and Compliance in Biologics, based in Shanghai, China. The role involves overseeing compliance with quality management systems, managing regulatory inspections, and providing guidance on quality assurance topics within the pharmaceutical sector.

Skills & Requirements

Must-have

  • 7 years pharmaceutical quality experience
  • Aseptic filling process expertise
  • FDA/EU cGMP regulatory knowledge
  • New facility startup readiness
  • Regulatory inspection management

Nice-to-have

  • SAP and Veeva tool proficiency
  • Strong stakeholder management skills
  • Agile adaptability to changes
  • Diplomatic communication abilities
  • International regulatory network exposure

Key Requirements

  • Degree in pharmaceutical sciences or related discipline
  • Minimum 7 years in QA/GMP/compliance
  • Fluent English communication skills

Work Rights

Not specified

Tailored Resume

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