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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