UK-I Quality Manager – RP/RPi

We are currently seeking a UK-I Quality Manager – RP/RPi to join Angelini Pharma UK-I. This is a key leadership role for an experienced quality professional who will oversee local Quality activities, ensure GDP and GVP compliance with UK-I regulations and Angelini Pharma standards, and act as Responsible Person (RP) and Responsible Person Import (RPi).

Position Purpose

As UK-I Quality Manager – RP/RPi, you will lead the local Quality Management System (QMS), ensuring that Angelini Pharma UK-I operates in compliance with applicable GxP, local regulations and company requirements.

You will act as the main local reference point for quality, while working closely with the Country Manager, local leadership team, Global Quality and external partners.

In this role, you will also hold the regulated responsibilities of RP and RPi, ensuring compliant wholesale distribution and import activities under the relevant legislation.

Key Responsibilities

Quality & Compliance (GDP and GVP)

• Lead and maintain the local Quality Management System in line with local regulations and Angelini Pharma global standards.
• Ensure implementation and oversight of local quality processes, including training, deviations, complaints, CAPAs, change controls, escalations, and quality investigations.
• Maintain local quality documentation and records, ensuring integrity, accessibility, and retention compliance.
• Monitor quality metrics, hold management review, and drive continuous improvement initiatives.
• Coordinate inspections, audits, self-inspections, and follow-up actions with authorities, partners, and internal stakeholders.
• Qualification and oversight of suppliers, customers, contractors, and other GxP-relevant third parties.
• Act as local quality representative with authorities and support product quality defect reporting when required.
• Partner with cross-functional teams including Medical, Pharmacovigilance, Regulatory Affairs, Supply, Logistics, and Customer Service on quality-related matters.

RP / RPi Responsibilities

• Fulfill the legal and operational responsibilities of the Responsible Person (RP) for activities covered by the Wholesale Distribution Authorisation (WDA(H)).
• Fulfill the duties of Responsible Person Import (RPi) in accordance with UK legislation.
• Maintaining GDP-compliant systems and records for all relevant wholesale distribution and import activities.
• Management of customer and supplier qualification, product returns, complaints, recalls, self-inspections, and GDP-related quality events.
• Appropriate verification of QP certification and release checks for medicinal products imported into Great Britain.
• Act as key contact with the MHRA for GDP and quality-related matters, including recalls, shortages, defective medicines, and falsified medicines where applicable.

Qualifications & Requirements

Education

• Bachelor’s degree or equivalent in Pharmacy, Chemistry, Medicine, Biology, Pharmaceutical Sciences, Health Sciences, or another relevant life science discipline.

Experience

• Minimum 3 years of experience in a regulated pharmaceutical or healthcare environment as Quality Assurance role.
• Strong experience within GxP activities.
• Experience in hosting GMP/GDP regulatory inspections.
• Experience with quality systems, supplier oversight, audits, and regulatory compliance.

RP / RPi Requirements

• Resident in the UK.
• Eligible for and/or registered with the MHRA as RP and RPi.
• Direct experience in MHRA GMP/GDP inspections as auditee.
• Relevant experience required under UK regulations for RP/RPi activities.

Language Skills

Technical Skills

• Strong knowledge of UK pharmaceutical regulations, GDP, GxP, and quality systems.
• Familiarity with EHS compliance and reporting is an advantage.
• Good command of Microsoft Office and electronic systems used within GxP area (e-DMS, e-QMS, ERP, etc.).

Personal Skills

• Leadership and ownership mindset.
• Excellent communication and stakeholder management skills.
• Ability to work effectively across local and global teams.
• Strong analytical, problem-solving, and decision-making capabilities.
• High attention to detail, with a pragmatic and continuous improvement approach.

Angelini Pharma researches, develops, and commercializes solutions with a predominant focus on Brain Health and Consumer Healthcare. The company has:

• More than 40 business partners
• Products marketed in over 70 countries
• Direct presence in 20 countries

The salary for this role starts from GBP 59,000 gross per year, depending on experience and location. The offer is determined based on gender-neutral criteria, including relevant skills, competencies, and experience.

Angelini Pharma is an equal Opportunity Employer. We believe that diversity is a huge value that contributes to individual and company success. We are committed to create a diverse and inclusive environment.