Quality Assurance Manager

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.

• 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 GMP 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

• 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
• Experience implementing or enhancing electronic Quality Management Systems (eQMS)