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