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 industry and contribute towards manufacturing operations and senior leadership team.
Desired Skills and Experience
Quality Assurance, Management, ISO, FDA, CAPA, QMS, CFR, Operations, Manufacturing, Continuous Improvement