Sr Manager, Quality Assurance

Gilead Sciences

10+ years qa experience in pharmaceutical industry
Master of science degree required
In-depth knowledge of gqp, gmp, gdp regulations
The role involves managing the Deputy of Quality Assurance Officer and overseeing operations within the commercial Quality Management System

Job Summary

  • The role involves managing the Deputy of Quality Assurance Officer and overseeing operations within the commercial Quality Management System.
  • Candidates must ensure compliance with GQP/GMP/GDP regulations while leading cross-functional projects and managing complex investigations.
  • This position requires maintaining strong relationships with stakeholders including supply chain, regulatory affairs, and manufacturing to align product distribution with global standards.

Matching Summary

The role involves managing the Deputy of Quality Assurance Officer and overseeing operations within the commercial Quality Management System.

Skills & Requirements

Must-have

  • 10+ years QA experience in pharmaceutical industry
  • Master of Science degree required
  • In-depth knowledge of GQP, GMP, GDP regulations
  • Experience with Electronic Document Management Systems
  • Fluent Japanese and English business communication skills

Nice-to-have

  • Six Sigma and Kaizen methodology expertise
  • Biologic and Cell Therapy experience preferred
  • ASQ certification (CQA, CQE, CQM)
  • Risk management tools like FMEA or HACCP
  • Computer System Validation (CSV) knowledge

Key Requirements

  • 10+ years relevant QA experience
  • Master of Science degree
  • 5+ years QMS experience
  • Japanese language proficiency
  • GxP application experience

Work Rights

Not specified

Tailored Resume

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