Regional Quality Systems Mgr

FRESENIUS MEDICAL CARE

Not specified; not specified; not specified
5-8 years quality assurance experience
Strong knowledge of fda regulatory requirements
Thorough technical knowledge of cgmps and gdps
The Regional Quality Systems Manager provides guidance for site development, deployment, and maintenance of strategic quality requirements for Distribution Centers

Job Summary

  • The Regional Quality Systems Manager provides guidance for site development, deployment, and maintenance of strategic quality requirements for Distribution Centers.
  • This role requires maintaining a physical presence at each Distribution Center within the assigned region a minimum of once per quarter.
  • The incumbent is responsible for formulating policy changes, influencing compliance across all DC sites, and ensuring adherence to cGMP and ISO regulations.

Matching Summary

The Regional Quality Systems Manager provides guidance for site development, deployment, and maintenance of strategic quality requirements for Distribution Centers.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 5-8 years Quality Assurance experience
  • Strong knowledge of FDA regulatory requirements
  • Thorough technical knowledge of cGMPs and GDPs
  • Prior supervisor experience required
  • Hands-on experience interacting with regulatory authorities

Nice-to-have

  • Engineering background preferred
  • Professional quality discipline certifications desired
  • Experience as a health authority or regulator
  • Advanced degree desirable
  • Innovative solutions to cross-functional issues

Key Requirements

  • Bachelor's Degree in Chemistry or related field
  • Master's degree with 3 years' experience option
  • PhD without experience option
  • CQE, CQA, CQM or RAB certification desired
  • Prior supervisor experience required

Work Rights

Not specified

Tailored Resume

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