Quality Manager / Responsible Person (RP)

An exciting opportunity for an experienced Quality Manager / Responsible Person (RP) to join a growing biosimilars organisation backed by one of the world's largest healthcare companies. This role will provide GDP quality oversight across a virtual pharmaceutical supply chain, supporting wholesale distribution, logistics providers, manufacturing partners, and suppliers while ensuring full compliance with regulatory requirements.

This position offers excellent long-term career progression, including the opportunity to develop into the designated Responsible Person role within a highly experienced quality team supporting both European and US-facing operations.

• Act as Responsible Person (RP) or Deputy Responsible Person (DRP) for wholesale distribution activities.
• Maintain and continuously improve the GDP Quality Management System (QMS).
• Ensure compliance with GDP, GMP, WDA requirements, and applicable regulatory standards.
• Manage quality events including deviations, CAPAs, complaints, change controls, and risk assessments.
• Oversee temperature-controlled distribution activities and logistics service providers.
• Support supplier qualification, audits, quality agreements, and ongoing supplier oversight activities.
• Collaborate with CMOs and manufacturing partners on investigations, compliance activities, and product quality matters.
• Participate in internal, supplier, customer, and regulatory audits and inspections.
• Support inspection readiness activities and act as a key quality contact for regulatory authorities where required.
• Provide quality leadership across distribution, supply chain, and external partner operations.

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Microbiology, or a related discipline.
• 8+ years' experience within pharmaceutical Quality Assurance and GDP-regulated environments.
• Previous Responsible Person (RP) or Deputy Responsible Person (DRP) experience is essential.
• Experience being named on a Wholesale Distribution Authorisation (WDA) licence is essential.
• Strong knowledge of EU GDP regulations and pharmaceutical supply chain operations.
• Experience managing deviations, CAPAs, complaints, change controls, and quality systems.
• Experience supporting supplier qualification, audits, and third-party oversight activities.
• Experience working within wholesale distribution, virtual pharmaceutical, or outsourced supply chain environments is highly desirable.
• GMP manufacturing quality experience and CMO oversight experience would be advantageous.