Quality Manager

Overview

Quality Manager - Responsible Person (UK)Location:

Birmingham, UK (on-site; up to 1 day/week remote after probation)Reports to:

Chief Quality OfficerContract:

Full-time, permanentRP Experience:

Preferable, but training can also be provided.Role purposeOwn and continually improve the

UK Quality Management System (QMS)

and serve as

Responsible Person (RP) . Safeguard licence compliance, lead inspections/audits, and embed GDP best practice across the UK operation.Key responsibilities

Licences, certifications and inspection readinessMaintain

WDA(H)

and

GDP

certification,

ISO 9001:2015 ,

ISO 14001:2015 , and Home Office Controlled Drug licences; ensure continuous inspection readiness.Host regulatory inspections and manage responses through to closure.QMS ownership and eQMS controlOwn the UK

QMS

and

eQMS : keep controlled documents current and effective; ensure timely reviews and archiving.Maintain and update SOPs, Work Instructions,

Site Master File , and

Quality Policy .Audit programmeCreate and manage the

audit and self-inspection plan .Perform self-inspections/internal audits; audit service providers, affiliates, and business partners.Complaints and customer qualityOversee service-related quality complaints and escalations.Record, track, and communicate

UK product quality complaints

to the

Marketing Authorisation Holder (MAH)

and affected customers.GDP, training and cultureChampion

GDP

across all processes; drive continuous improvement.Deliver role-appropriate GDP training; ensure training records are complete and current.Risk, change and deviation managementApply

ICH Q9 Quality Risk Management ; perform dynamic risk assessments.Lead timely closure of

change controls

and

deviations , including root-cause analysis and

CAPA

management aligned to legislation/guidance.KPIs, data and supplier qualityAnalyse trends and generate

KPIs

for management review; use metrics (incl. complaints) to drive process and supplier performance.Qualify and periodically re-qualify key suppliers; create/update

Quality Technical Agreements

and Service Agreements.Validation and systemsPrepare/review validation documents for

computerised systems

and

GDP activities

(e.g., temperature mapping, transport validation).Site operations and compliance intelligenceContribute to site management (HandS, security, temperature monitoring/control).Track emerging legislation and

MHRA alerts

for ongoing compliance and customer qualification.Monitor temperature excursions from hauliers/carriers and assess using medical information data.Mandatory criteria

Location:

Birmingham.Language:

English.Work pattern:

On-site; up to

1 day/week remote

after probation.Professional requirements

Training and proven expertise in the

pharmaceutical industry

and

GMP .Extensive knowledge of

UK GDP

and

ISO 9001 .Preferably prior experience as

Responsible Person (RP) .Strong experience in a

WDA(H)

quality function (licensing, inspections, GDP ..... full job details .....