Are you passionate about quality and precision? Join our client as a Distribution Director and help ensure top-tier standards every day.
Proclinical is seeking a Director, Distribution QA (GDP), RP/RPi to lead and enhance the quality assurance framework for distribution activities. In this role, you will collaborate closely with leadership to ensure compliance, drive process harmonization, and oversee Responsible Persons across the organization. This position also includes acting as the Responsible Person (RP) and Responsible Person for Importation (RPi) in the UK, ensuring regulatory compliance and operational continuity.
Responsibilities:
Ensure compliance with Wholesale Dealer Authorisations (WDA), MHRA regulations, EU GDP guidelines, and other relevant standards.Act as the RP and RPi for the release of imported products into the UK market.Liaise with regulatory authorities, including preparing for and participating in inspections.Develop, implement, and maintain effective quality management systems (QMS) for distribution processes.Drive harmonization and continuous improvement of distribution quality processes and SOPs.Oversee internal and external audits related to distribution activities.Supervise UK and export distribution operations, ensuring compliance and efficiency.Manage risk by overseeing recalls, compliance checks, and quality-related decisions.Collaborate with suppliers, distributors, and customers to ensure qualification and compliance.Provide leadership and training to foster a strong quality culture across the organization.Key Skills and Requirements:
Background in pharmacy, chemistry, biology, engineering, or a related field.Eligibility to act as an RP and RPi in the UK.Experience in quality system processes such as deviation management, CAPA, and change control.Knowledge of EU GDP guidelines, MHRA expectations, and supply chain processes.Familiarity with electronic QMS platforms like Veeva.Strong attention to detail, problem-solving skills, and critical thinking.Ability to work independently and collaboratively within a team.Excellent communication skills, both written and verbal.Proficiency in additional European languages (e.g., German, Spanish, French) is a plus.