Regulatory & Quality Ops Manager – UK with RP Path

Enua Pharma GmbH; Greater London; On-site; GBP 70,000 - 95,000; Full time

Benefits offered by this job

Pathway to becoming Responsible Person

Ownership in UK start-up environment

Exposure to regulatory, supply chain &

RP training support

London office-based small team

Job summary

Enua Pharma GmbH is seeking an experienced Regulatory & Quality Operations Manager for our London HQ to own UK QA and GDP/GMP compliance. You will build and drive the quality management system, draft SOPs, manage deviations and CAPAs, and act as a key liaison with MHRA and Home Office while progressing toward the Responsible Person role.

You will collaborate across operations, commercial and group quality, shaping QA processes for a growing UK business and ensuring inspection readiness from day

Qualifications

• 4+ years in GDP and/or GMP quality or regulatory roles in the UK pharmaceutical industry
• In-depth knowledge of MHRA GDP requirements and RP responsibilities
• Hands-on QA experience with SOPs, deviations/CAPAs, training records and closure actions
• Direct experience of MHRA inspections or audits
• Comfortable in a fast-changing start-up environment with limited resources
• Excellent written and spoken English
• Right to work in the UK

Responsibilities

• Maintain WDA(H) and Home Office licences, variations and submissions
• Support and potentially be named RP on WDA(H) after probation
• Lead MHRA and Home Office inspections and close findings
• Be the main contact for MHRA, Home Office and regulatory consultants
• Own GDP quality management system; draft/maintain SOPs, deviations, CAPAs and change controls
• Deliver day-to-day QA activities: document control, record reviews, training tracking
• Support electronic QMS selection and transition while ensuring inspection readiness
• Build practical QA processes suitable for a growing business without compromising GDP or patient safety
• Qualify and onboard suppliers, manufacturers, 3PLs and customers
• Run audits of suppliers/3PLs and manage ongoing oversight
• Oversee import, release and distribution of unlicensed medicines in line with GDP and CD requirements
• Handle complaints, recalls, temperature excursions and returns
• Provide regulatory input on new products, partners and supply chain changes
• Collaborate with operations, commercial and group quality to grow the QA function
• Report quality metrics and risks to leadership

Skills

GDP compliance

GMP compliance

Regulatory affairs

QA documentation

MHRA inspections

SOP drafting

RP experience

English proficiency

Education

Pharmacy degree or life sciences

Job description

Enua Pharma GmbH is seeking an experienced Regulatory & Quality Operations Manager for our London HQ to own UK QA and GDP/GMP compliance. You will build and drive the quality management system, draft SOPs, manage deviations and CAPAs, and act as a key liaison with MHRA and Home Office while progressing toward the Responsible Person role.

You will collaborate across operations, commercial and group quality, shaping QA processes for a growing UK business and ensuring inspection readiness from day