Director, Drug Product Quality Assurance

Genentech

Hillsboro, OR, US
Base: $142,600 - $263,000; bonus/equity: not speci...
Quality oversight for cgmp operations
Batch production record review
Deviation investigation and resolution
You will lead a dynamic and inclusive team responsible for ensuring Quality supply of life-saving medicines for our patients

Job Summary

  • You will lead a dynamic and inclusive team responsible for ensuring Quality supply of life-saving medicines for our patients.
  • This role provides Quality leadership for key initiatives to establish Hillsboro Technical Operations as a center of excellence for aseptic drug product manufacturing.
  • As a member of the Quality Site Leadership Team, you will drive site strategy realization, networking activities, coordination, cross-functional planning and decision making.

Matching Summary

You will lead a dynamic and inclusive team responsible for ensuring Quality supply of life-saving medicines for our patients.

Salary

Base: $142,600 - $263,000; Bonus/Equity: Not specified; Benefits: Provided

Skills & Requirements

Must-have

  • Quality oversight for cGMP operations
  • Batch production record review
  • Deviation investigation and resolution
  • Regulatory compliance management
  • Continuous improvement culture
  • Leadership of cross-functional teams

Nice-to-have

  • Experience in parenteral facility
  • Strategic and systems thinking
  • Promoting positive safety culture
  • Lean principles and methodologies
  • Inspiring and motivating teams
  • Cross-functional planning and decision making

Key Requirements

  • BS/MS degree in Science or Engineering
  • 15+ years bio/pharmaceutical experience
  • Experience in FDA regulated environment
  • In-depth understanding of cGMP and regulatory requirements
  • Direct group management experience
  • Experience implementing continuous improvement
  • Ability to manage regulatory inspections

Work Rights

Not specified

Tailored Resume

Cover Letter