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