Regulatory & Quality Operations Manager (m/f/d) – UK

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

We are a fast-growing European healthcare group operating across medical cannabis, digital health and regulated healthcare services. While we have an established, profitable European business and central group support, our UK operation is in a start-up and build-out phase. We are establishing the systems, processes and ways of working needed to scale licensed wholesale distribution alongside a telemedicine clinic and technology business.

Our UK wholesale business holds a WDA(H) and a Schedule 2 Controlled Drug licence, and distributes cannabis-based products for medicinal use (CBPMs) to pharmacies and wholesalers across the UK.

Location: London (office-based), with regular time at our licensed site in Welwyn Garden City and with our 3PL partners

The role

We’re looking for an experienced Regulatory & Quality Operations Manager to take hands-on ownership of UK quality assurance (QA), our GDP quality management system and day-to-day licence compliance, with a pathway to becoming the Responsible Person (RP) for our WDA(H).

This is a genuine UK start-up environment, not a large, fully resourced corporate QA department. You will need to be equally comfortable building processes from scratch, improving existing documentation and completing routine QA tasks yourself. Priorities will evolve as the business grows, so we need someone practical, adaptable, organised and willing to roll up their sleeves. You will work closely with our Director of Operations & Commercial, external RP and group quality team in Germany, while taking clear ownership of UK delivery.

Key responsibilities

Licences & regulatory compliance

Maintain our WDA(H) and Home Office Controlled Drug licences, including variations, import/export licences and Home Office online submissions

Support our Responsible Persons from day one and, subject to MHRA approval, be named as RP on our WDA(H) after successful completion of the 6-month probation period (or earlier) – working alongside our external RP, with the prospect of becoming the main RP

Lead preparation for MHRA and Home Office inspections and close out any findings

Act as the main day-to-day contact for the MHRA, the Home Office and external regulatory consultants

Quality management system

Own, operate and continually improve our GDP quality management system, including drafting and maintaining SOPs, processing deviations and CAPAs, change controls, risk assessments, training records and self-inspections

Personally deliver day-to-day QA activity: document control, record reviews, compliance trackers, training follow-up, supplier files and timely closure of quality actions

Help select and implement an electronic QMS while maintaining effective, inspection-ready systems and records during the transition

Build practical, proportionate QA processes suitable for a growing business without compromising GDP compliance or patient safety

Qualify and onboard suppliers, manufacturers, 3PL warehouse partners and customers, including bona fide checks and quality technical agreements

Run audits of suppliers and 3PLs (desktop and on-site) and manage ongoing oversight

Oversee import, release and distribution of unlicensed medicines in line with GDP and controlled drug requirements

Handle complaints, recalls, temperature excursions and returns

Leadership & business partnering

Take ownership of both strategic improvements and routine execution; identify what needs doing, prioritise independently, document decisions and escalate material risks appropriately

Give regulatory input on new products, partners and supply chain changes

Work collaboratively across operations, commercial and group quality; manage consultants where needed and help develop the QA function as the UK business grows

Report quality metrics and risks to the Director of Operations & Commercial and the management team

What we’re looking for

Required

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 (EU GDP Guidelines as applied in the UK) and the RP’s responsibilities

Proven hands-on QA experience, including personally drafting and controlling SOPs, managing deviations/CAPAs, maintaining training and qualification records and driving actions to closure

Direct experience of MHRA inspections or audits

Comfortable in an early-stage, fast-changing business with limited initial resources; proactive, detail-oriented and willing to carry out administrative QA work as well as make independent compliance decisions

Excellent written and spoken English

Right to work in the UK

Preferred

Previous experience as RP or Deputy RP on a WDA(H), or completion of a recognised RP training course

Experience with Home Office controlled drug licensing, including import/export licences

Pharmacist, or a degree in pharmacy or a life sciences subject

Experience onboarding or overseeing 3PL providers

Experience setting up, improving or scaling QA systems in a start-up, scale-up or lean pharmaceutical operation

What we offer

A clear pathway towards becoming the named Responsible Person, alongside the opportunity to build and shape the UK QA function

Meaningful ownership from day one in a hands-on UK start-up environment, with support from an established European healthcare group

Exposure across regulatory, supply chain and commercial operations in a vertically integrated business

A London office-based role in a small, collaborative team where you can see the direct impact of your work