We have a current opportunity for a Director Site Quality Manager - Ilfracombe, Devon on a permanent basis.
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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