Manager, Gmp Operational Analytical Quality (hybrid)

Vrtx

Boston, MA, United States
Base: $118,400 - $177,600; bonus/equity: eligible ...
On-site
Cgmp principles and application
Global gmp requirements
Quality oversight of investigations
The Quality Manager provides quality oversight and sets strategy for process validation, cleaning validation, method validation, and/or product stability activities

Job Summary

  • The Quality Manager provides quality oversight and sets strategy for process validation, cleaning validation, method validation, and/or product stability activities.
  • Demonstrates appropriate quality oversight of root-cause analysis and product impact for product quality investigations, ensuring appropriate CAPA actions are identified and addressed.
  • Develops and/or maintains quality systems to support of manufacture, and testing in GMP QC laboratories.

Matching Summary

The Quality Manager provides quality oversight and sets strategy for process validation, cleaning validation, method validation, and/or product stability activities.

Salary

Base: $118,400 - $177,600; Bonus/Equity: eligible for annual bonus and annual equity awards; Benefits: inclusive market-leading benefits

Skills & Requirements

Must-have

  • cGMP principles and application
  • global GMP requirements
  • quality oversight of investigations
  • root-cause analysis and CAPA
  • quality systems for GMP QC labs
  • method validation
  • product stability activities

Nice-to-have

  • mentoring junior staff
  • transferring technical knowledge
  • phase appropriate decisions
  • Vertex Core Values and leadership behaviors

Key Requirements

  • Bachelor's degree in scientific or allied health field
  • 4 years of experience
  • Experience in Analytical Laboratory
  • Operational QA experience in analytical/manufacturing setting
  • RCA tools/methodology/technical writing
  • Lean Six Sigma Training

Work Rights

Not specified

Tailored Resume

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