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).