Quality Manager

Quality Manager - Cwmbran (Near Newport, South Wales) A leading CRO is looking for a Quality Manager to join its Cwmbran team, taking ownership of day-to-day Quality Assurance operations and ensuring both GMP and non-GMP activities meet the highest standards of compliance, integrity, and client commitment. In this pivotal role, you'll provide hands-on QA leadership across the full spectrum of quality system activities - from laboratory oversight and supplier audits to inspection readiness and documentation review. You'll be expected to apply pragmatic, risk-based judgement suited to a dynamic contract laboratory environment where regulated and non-regulated activities coexist. As a senior quality practitioner and people manager, you'll guide operational teams, coach staff on GMP and non-GMP expectations, and step in to deputise for the Head of Quality when required. This is a role for someone who thrives on responsibility, collaboration, and driving a culture of compliance and continuous improvement. Key Responsibilities • Provide routine QA oversight of GMP and non-GMP laboratory activities • Maintain and improve the Pharmaceutical Quality System (PQS), including deviations, CAPAs, change controls, and investigations • Arrange, host, and respond to client audits and regulatory inspections • Lead, perform, and report on internal audits in line with the site audit programme • Conduct supplier audits, oversee supplier qualification, and maintain the Approved Supplier List • Apply data integrity and CSV principles across GxP systems • Support or lead implementation of electronic Quality Management Systems (eQMS) • Line-manage 2 QA direct reports and mentor up to 4 indirect reports • Identify training needs, coach staff, and promote a strong quality culture • Drive continuous improvement initiatives across QA processes and systems What We're Looking For • Significant QA experience within a GMP-regulated environment • Experience in a contract laboratory or service-based organisation conducting GMP and non-GMP activities • Demonstrable experience conducting internal and supplier audits • Proven track record supporting and hosting client and regulatory inspections • Strong working knowledge of EU GMP, FDA CFRs, Annex 11, and ICH Q8-Q10 • Sound understanding of data integrity and CSV principles • Approachable, credible, and collaborative leadership style • Confident communicator with internal stakeholders, clients, and regulators • Practical, solution-focused, and calm under inspection conditions Desirable: • Experience implementing or enhancing electronic Quality Management Systems (eQMS) • QMS Lead Auditor qualification • Certified training within GxP