Regional Quality Systems Mgr

Fresenius Medical Care

Knoxville, TN, United States
Quality systems implementation
Cgmp and iso regulations
Audit program development
Provides guidance for site development, deployment and maintenance of strategic quality requirements for Distribution Centers within the assigned region

Job Summary

  • Provides guidance for site development, deployment and maintenance of strategic quality requirements for Distribution Centers within the assigned region.
  • Assures compliance programs are implemented and maintained at applicable sites, works with business partners to mitigate compliance risk, and provides leadership to the Distribution Center organization.
  • Responsible for the development and maintenance of an active audit program, formulates policy changes, and ensures key Distribution processes are defined, documented, and controlled.

Matching Summary

Provides guidance for site development, deployment and maintenance of strategic quality requirements for Distribution Centers within the assigned region.

Skills & Requirements

Must-have

  • Quality Systems implementation
  • cGMP and ISO regulations
  • audit program development
  • regulatory compliance
  • risk management
  • distribution center operations

Nice-to-have

  • cross-functional compliance solutions
  • mentoring junior staff
  • teamwork and customer focus
  • innovative solutions

Key Requirements

  • 5 - 8 years' experience in Quality Assurance, Regulatory Affairs and/or compliance
  • Bachelor's Degree in Chemistry or related field
  • Prior supervisor experience
  • Hands-on experience interacting with regulatory authorities

Work Rights

Not specified

Tailored Resume

Cover Letter