Head of Site Quality


Barnstaple
Permanent
Benefits + bonus
Quality
PR/551640_1751555053
Head of Site Quality

Our client, a leading international med tech company, are looking for the pivotal role of Head of Site Quality. Collaborating closely with executive leadership and a dedicated quality team, you will be responsible for the enhancement of the Quality Management System (QMS) to ensure continuous improvement and regulatory compliance.

Responsibilities:

  • Spearhead Quality Leadership & Compliance, overseeing QA/QC functions and ensuring adherence to regulatory standards
  • Champion Quality Management System (QMS) optimisation and efficiency
  • Collaborate with site and global leadership to navigate process changes, advocate for site-specific requirements, and implement customer-centric solutions during change management
  • Foster Team Development & Performance by cultivating a high-performing quality department
  • Lead Audits and Reporting activities, conducting Quality Management Reviews, monitoring KPIs, hosting audits, and serving as the site's representative
  • Navigate FDA/EPA-regulated manufacturing environments with precision
  • Utilise Regulatory and Quality Expertise encompassing ISO, FDA, cGMPs, CFR, Controls, CAPA, and more
  • Manage Complaints, audits, and risk effectively using quality statistical methods, Lean Manufacturing principles, Six Sigma methodologies, and Root Cause Analysis tools

Qualifications:

  • Hold a degree in Science, Business, Engineering, or related fields (practical expertise also considered)
  • Quality Assurance, Quality Engineering, or Manufacturing Operations
  • Experience in Life Sciences sectors such as Biotechnology, Medical Device, Biopharma, or similar industries

On offer is the opportunity to work for a marquee name in the med tech industry and contribute towards manufacturing operations.

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