Quality Compliance Senior Specialist/associate Manager

Roche

Shanghai, China
Not specified
5+ years quality unit experience in pharmaceutical industry
Knowledge of cgmp and local/international gmp regulations
Experience with ha inspections and audit management
Roche is seeking a Quality Compliance Senior Specialist/Associate Manager in Shanghai, China, to lead regulatory compliance, inspection management, and quality assurance in the pharmaceutical industry. The ideal candidate will have over five years of relevant experience, particularly in quality systems and compliance principles

Job Summary

  • The role involves leading regulatory compliance for SRPL GMP/MAH and managing external communications with Health Authorities.
  • Candidates will host and manage internal and external audits while ensuring timely responses to inspection requests.
  • Roche fosters a culture of personal expression and genuine connections where every voice matters in delivering life-changing healthcare solutions.

Matching Summary

Match Score: 85

Roche is seeking a Quality Compliance Senior Specialist/Associate Manager in Shanghai, China, to lead regulatory compliance, inspection management, and quality assurance in the pharmaceutical industry. The ideal candidate will have over five years of relevant experience, particularly in quality systems and compliance principles.

Skills & Requirements

Must-have

  • 5+ years Quality Unit experience in pharmaceutical industry
  • Knowledge of cGMP and local/international GMP regulations
  • Experience with HA inspections and audit management
  • Bachelor's degree in Pharmacy, Science, or Biology
  • Strong English communication skills

Nice-to-have

  • Leadership competencies and integrity modeling
  • Experience with SRPL GMP/MAH implementation
  • Ability to collaborate with global functions
  • Continuous improvement mindset for quality systems

Key Requirements

  • Bachelor's Degree required; Graduate degree preferred
  • Minimum 5 years Quality Unit experience in pharma
  • Proficiency in English reading, writing, speaking, and listening

Work Rights

Not specified

Tailored Resume

Cover Letter