Manufacturing Division Quality Control Associate Director

Laboratory Animal Management Association

Saitama, Japan
Hybrid
Cgmp regulations
Quality control management
People leadership
The Associate Director, Quality Control will lead a team of quality control laboratory analysts and manage quality testing for raw materials, components, finished drug substances, or final drug product

Job Summary

  • The Associate Director, Quality Control will lead a team of quality control laboratory analysts and manage quality testing for raw materials, components, finished drug substances, or final drug product.
  • This role ensures all analytical testing activities comply with cGMP, safety, and environmental requirements, while also managing investigations and implementing corrective and preventive actions.
  • Responsibilities include forecasting resource needs, managing budgets, developing a continuous improvement framework, and supporting site improvement programs to enhance compliance and productivity.

Matching Summary

The Associate Director, Quality Control will lead a team of quality control laboratory analysts and manage quality testing for raw materials, components, finished drug substances, or final drug product.

Skills & Requirements

Must-have

  • cGMP Regulations
  • Quality Control Management
  • People Leadership
  • CAPA Management
  • Analytical Methodology
  • Regulatory Experience

Nice-to-have

  • Strategic Thinking
  • Customer Focus
  • Continuous Improvement Mindset
  • Problem-Solving Attitude
  • Coaching and Mentoring

Key Requirements

  • Bachelor’s degree in science/Life Science, Analytical Chemistry, Pharmaceutical Science, Engineering or proven relevant experience
  • Minimum 8 years of applied professional work experience in quality operations/quality control in pharmaceutical manufacturing
  • At least 3 years of people management experience
  • Demonstrated experience in change and project management
  • Effective English and Japanese communication skills

Work Rights

Not specified

Tailored Resume

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