Senior Manager Site Quality

5 days ago


Devon, United Kingdom EPM Scientific Full time

In this role, you will have the opportunity to:

  • Represent the Ilfracombe site as the Quality Management Representative and lead management reviews
  • Responsible for the leadership & development of the QA site function.
  • Responsible for implementing the QMS
  • Ensure QMS procedures, work instructions, and IT System effectively support the Ilfracombe site organization - Collaborate with Global QMS Subject Matter Experts (SME) as required.
  • Support the Global QMS team on Global process and procedure changes and represent the needs of the site during change management and continuous improvement discussions.
  • Accountable for setting & monitoring Quality KPI’s including, reporting on performance/ trend insights within business reviews.
  • Ensure effective communication style with stakeholders and establish cross functional operating mechanisms, where appropriate to ensure Quality goals are met.

The essential requirements of the job include:

  • Minimum, Bachelor's degree, preferably in a Science or Engineering discipline
  • A minimum of 5 years working in Quality Assurance/Quality Engineering or Product Engineering -within Life Science, Medical Device or Biopharma manufacturing environments
  • 2-4 years of supervisory experience
  • Knowledge of ISO, FDA, cGMP’s, and CFR requirements
  • Experience with Root Cause Analysis Tools, Lean Manufacturing, and Six Sigma.
  • Knowledge of quality statistical methods and tools
  • Experience supporting validation and technology transfer activities.



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