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

Posted 10 hours 39 minutes ago by Enua Pharma GmbH

Permanent
Full Time
Legal Jobs
London, United Kingdom
Job Description
About us

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

Suppliers, customers & 3PLs

  • 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 escalated 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

  • Support for professional development, including RP training

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