Senior Manager Site Quality

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.