Sr Manager, Validation

Thermo Fisher Scientific UK

Greenville, NC, US
Manage professional support staff and contractors
Process validation of manufacturing equipment, utility systems, facilities, and processes
Represent department in fda meetings and audits
Manage a professional support staff and contractors responsible for process validation of all products marketed by the company and produced by the company, independent contractors, and international company subsidiaries

Job Summary

  • Manage a professional support staff and contractors responsible for process validation of all products marketed by the company and produced by the company, independent contractors, and international company subsidiaries.
  • Develops, approves, executes, and presents all validation master plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs.
  • Prepares and defends five-year plans and annual budgets for the department by assessing manpower and capital needs.

Matching Summary

Manage a professional support staff and contractors responsible for process validation of all products marketed by the company and produced by the company, independent contractors, and international company subsidiaries.

Skills & Requirements

Must-have

  • Manage professional support staff and contractors
  • Process validation of manufacturing equipment, utility systems, facilities, and processes
  • Represent department in FDA meetings and audits
  • Develop and maintain plant-wide change control system
  • Provide process validation guidance to domestic contractors and subsidiaries

Nice-to-have

  • Motivate, energize, and retain key staff
  • Work in a fast-paced environment under pressure
  • Maintain a high degree of confidentiality
  • Establish and maintain effective working relationships

Key Requirements

  • 10+ years of validation experience
  • Five to eight years of progressive leadership experience
  • Exceed five years of Pharmaceutical or Biotechnical Industry experience
  • Minimum of two years of demonstrated experience in sterilization validation
  • Strong project management experience

Work Rights

Not specified

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