Overview
Quality Manager - Responsible Person (UK)
Location: Birmingham, UK (on-site; up to 1 day/week remote after probation)
Reports to: Chief Quality Officer
Contract: Full-time, permanent
RP Experience: Preferable, but training can also be provided.
Role purpose
Own 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 & inspection readiness
* Maintain 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 & eQMS control
* Own 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 programme
* Create and manage the audit & self-inspection plan.
* Perform self-inspections/internal audits; audit service providers, affiliates, and business partners.
Complaints & customer quality
* Oversee 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 & culture
* Champion GDP across all processes; drive continuous improvement.
* Deliver role-appropriate GDP training; ensure training records are complete and current.
Risk, change & deviation management
* Apply 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 & supplier quality
* Analyse 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 & systems
* Prepare/review validation documents for computerised systems and GDP activities (e.g., temperature mapping, transport validation).
Site operations & compliance intelligence
* Contribute to site management (H&S, 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 compliance).
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