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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

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Quality Assurance Manager - FMCG Manufacturing
📍 Worcestershire

An established and growing manufacturing business is seeking an experienced Quality Assurance Manager to lead site quality and compliance activities within a fast-paced production environment.

This is a highly visible role with responsibility for maintaining and improving quality systems, audit readiness, product compliance, and operational standards across the site.

The Role

Key responsibilities will include:

Managing and developing the site Quality Management SystemLeading HACCP reviews and site risk assessmentsCoordinating internal audits and supporting external audits/customer visitsDriving GMP, hygiene, and continuous improvement standardsManaging investigations, non-conformances, CAPAs, and root cause analysisOverseeing SOP control and quality documentation processesSupporting supplier and packaging quality investigationsLeading and developing a quality team within a busy manufacturing operation

Candidate Profile

We are interested in speaking with candidates from a variety of regulated or high-volume manufacturing sectors, including:

Food manufacturingFMCGPharmaceuticalPersonal careCosmeticsOther high-care or highly regulated production environments

Direct sector experience is beneficial but not essential where candidates can demonstrate strong transferable quality and compliance expertise.

Key Requirements

Suitable applicants will ideally possess:

Proven experience within a QA or technical leadership roleStrong understanding of BRC standards and leading audit preparationExperience managing internal and external auditsHACCP qualification with practical implementation experienceKnowledge of QMS management and continuous improvement methodologiesStrong problem-solving and corrective action experiencePrevious people management and stakeholder engagement experienceA hands-on approach with the ability to work closely with operational teams

Additional Information

Experience working within a BRC-accredited manufacturing environment is highly desirable.HACCP Level 3 minimum preferred; Level 4 advantageous.The role combines both operational shop-floor presence and quality systems management responsibilities.Candidates should be comfortable leading teams, managing compliance activities, and supporting a strong quality culture across site.

This opportunity would suit an ambitious quality professional looking to make a significant impact within a dynamic manufacturing business. Please contact Rick @smart4 sciences for more info

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Smart4 Sciences - specialists in pharmaceutical recruitment - are currently supporting a highly compliant and quality-driven pharmaceutical organisation in London in their search for a Quality Manager / Responsible Person (RP).

This is a key hire within a regulated WDA/MIA/MAH environment, offering the opportunity to take ownership of the Pharmaceutical Quality Management System and act as a primary liaison with the Medicines and Healthcare products Regulatory Agency and EU authorities.

The Opportunity

This position sits at the heart of regulatory and operational compliance. You will play a critical role in maintaining and continuously improving the Pharmaceutical Quality System while ensuring full adherence to UK and EU regulatory frameworks.

The organisation operates within a highly regulated wholesale and authorisation landscape and requires a confident QA professional who thrives in inspection-led environments.

Key Responsibilities

Lead, maintain and enhance the Pharmaceutical Quality Management System (QMS)Oversee compliance across:Wholesale Distribution Authorisation (WDA)Manufacturer's/Importer's Authorisation (MIA)Marketing Authorisation Holder (MAH) activitiesEnsure full compliance with UK & EU GMP and GDP requirementsAct as primary contact for the Medicines and Healthcare products Regulatory Agency and EU regulatory bodiesLead regulatory inspections, manage responses and drive CAPA implementationOversee deviations, change controls, complaints, recalls, supplier qualification and self-inspectionsSupport regulatory strategy and business continuity initiatives

What We're Looking For

Significant QA experience within a WDA, MIA or MAH pharmaceutical environmentStrong working knowledge of UK & EU GMP and GDP regulationsProven experience hosting and managing regulatory inspectionsDirect liaison experience with the Medicines and Healthcare products Regulatory Agency and/or EU competent authoritiesIn-depth understanding of pharmaceutical QMS lifecycle processesStrong knowledge of UK Human Medicines Regulations and EU pharmaceutical directives

Qualifications

Degree in Pharmaceutical Sciences, Chemistry, Life Sciences or related disciplineEligibility to act as Responsible Person (RP) under WDA (highly desirable)GMP/GDP auditing or Quality Management certifications advantageous

Why Apply?

This is an excellent opportunity for a senior QA professional ready to step into a highly influential compliance role within a growing pharmaceutical business. The position offers strong visibility, regulatory ownership, and the opportunity to shape quality strategy in a dynamic wholesale environment.

If you are an experienced QA professional or RP open to a confidential discussion, contact Gareth Gooley @ Smart4 Sciences today to learn more.

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