Qa Associate Director (adc)

AstraZeneca

Establishment of quality management system
Contract manufacturing organization supervision
Delegated qualified person responsibilities
The role requires establishing and maintaining a Quality Management System for ADC products that complies with drug regulatory authorities

Job Summary

  • The role requires establishing and maintaining a Quality Management System for ADC products that complies with drug regulatory authorities.
  • As a Delegated Qualified Person, the incumbent ensures all marketed products undergo strict review before release to meet GMP requirements.
  • The position involves regular on-site inspections of Contract Manufacturing Enterprises to ensure effective integration of quality management systems.

Matching Summary

The role requires establishing and maintaining a Quality Management System for ADC products that complies with drug regulatory authorities.

Skills & Requirements

Must-have

  • Establishment of Quality Management System
  • Contract Manufacturing Organization supervision
  • Delegated Qualified Person responsibilities
  • GMP regulatory compliance knowledge
  • Antibody-Drug Conjugate experience

Nice-to-have

  • Cross-functional collaboration skills
  • Strong English communication abilities
  • Experience with MAH system operations
  • Resilience and strong execution capability

Key Requirements

  • Master's degree in Pharmacy, Chemistry, Biology, or related field
  • Over 10 years of pharmaceutical quality and production experience
  • At least 3 years of experience in ADC or biological product quality management
  • Familiarity with NMPA, EMA, and ICH regulations

Work Rights

Not specified

Tailored Resume

Cover Letter