UK Regulatory & Quality Operations Lead — RP Path

Enua; Greater London; On-site; GBP 75,000 - 110,000; Full time

Benefits offered by this job

Path to Responsible Person

London office-based role

Job summary

Enua is seeking an experienced Regulatory & Quality Operations Manager to own UK QA, GDP QMS and licence compliance, with a path to becoming the RP for WDA(H).

You will build processes from scratch in a start-up UK operation, work with the Director of Operations & Commercial, external RP and group quality, and drive QA activities across regulatory, supply chain and commercial functions.

Qualifications

• 4+ years in GDP and/or GMP quality or regulatory roles in the UK pharmaceutical industry, ideally in wholesale distribution, unlicensed medicines/specials or controlled drugs
• In-depth knowledge of MHRA GDP requirements and the RP responsibilities
• Hands-on QA experience including drafting/controlling SOPs, deviations/CAPAs, training records
• Direct experience of MHRA inspections or audits

Responsibilities

• Maintain WDA(H) and Home Office licences; variations and submissions
• Support the RP from day one and become RP after probation; collaborate with external RP
• Lead MHRA/Home Office inspections; close out findings
• Oversee GDP quality management system and SOPs; manage deviations/CAPAs
• Deliver day-to-day QA tasks: document control, training, supplier files
• Assist in selecting/implementing an electronic QMS; ensure inspection-ready records
• Build practical QA processes for a growing business without compromising GDP
• Qualify/onboard suppliers, manufacturers and 3PLs; manage technical agreements
• Run supplier/3PL audits and ongoing oversight
• Oversee import, release and distribution of unlicensed medicines
• Handle complaints, recalls, temperature excursions and returns
• Lead QA improvements; report metrics and risks to leadership
• Collaborate with operations, commercial and group quality; manage consultants

Skills

GDP/GMP QA

MHRA GDP

RP responsibilities

SOP drafting

CAPA management

Inspections

3PL onboarding

Quality systems

Documentation control

Job description

Enua is seeking an experienced Regulatory & Quality Operations Manager to own UK QA, GDP QMS and licence compliance, with a path to becoming the RP for WDA(H).

You will build processes from scratch in a start-up UK operation, work with the Director of Operations & Commercial, external RP and group quality, and drive QA activities across regulatory, supply chain and commercial functions.