Assoc. Dir, External Quality

Organon

Not specified; varies by country; no relocation pr...
Fully remote
Mandarin and english fluency required
Minimum 5 years pharma/biotech experience
Deep knowledge of global gmp regulations
The incumbent is accountable for all quality oversight activities at external manufacturing entities ensuring conformance to approved processes and regulatory requirements

Job Summary

  • The incumbent is accountable for all quality oversight activities at external manufacturing entities ensuring conformance to approved processes and regulatory requirements.
  • This role requires managing a team of Quality Assurance professionals while maintaining robust quality systems for the manufacture of various pharmaceutical products.
  • The position involves interacting with local Health Authorities in China to ensure compliance with domestic and foreign GMP regulations from a Marketing Authorization Holder perspective.

Matching Summary

The incumbent is accountable for all quality oversight activities at external manufacturing entities ensuring conformance to approved processes and regulatory requirements.

Salary

Not specified; Varies by country; No relocation provided

Skills & Requirements

Must-have

  • Mandarin and English fluency required
  • Minimum 5 years pharma/biotech experience
  • Deep knowledge of global GMP regulations
  • Experience with external entity oversight
  • Strong leadership and coaching skills

Nice-to-have

  • Prior multinational corporation QA experience
  • Contractual and financial awareness
  • Experience leading significant investigations
  • Previous regulatory inspection participation

Key Requirements

  • BS/MS in Science or Engineering
  • Fluency in Mandarin and English
  • 5+ years relevant industry experience
  • Global GMP regulatory knowledge

Work Rights

Not specified

Tailored Resume

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