Overall Purpose of the Role: An all-encompassing position as the Responsible Person/Responsible Person (import) (RP/RPi) and Quality Lead for CTHC UK. You will have full accountability for all aspects of the Quality Management System (QMS), GDP compliance and will be named on the company's WDA Licence. Furthermore, you will be responsible for performing GDP activities on product batches imported, manufactured, or distributed, including batch import release (RPi). You will also serve as the primary point of contact for CTHC UK with regulatory authorities, customers, and third-party contractors regarding QA, GDP and RA related activities. Due to the nature of the business operation, you will also lead aspects of Regulatory Affairs (RA) and will need to have Pharmacovigilance (PV) experience. Authority: You will be the authority on all activities across the business that fall within GDP, QA and RA and have the jurisdiction when deciding on the most effective and compliant actions to deploy for such activities. Key Responsibilities: Implementation and maintenance of the Quality Management System (QMS), including SOP generation and review, ensuring compliance with GDP regulations Provide the Leadership Team with regular reports regarding the Company’s Quality KPIs, including CAPA plan Deviation and change control management, training, outsourced activities, and self-inspections Product Quality Complaint (PQC) management Conduct supplier checks, approvals and audits, ensuring adherence to the relevant GDP/GMP standards. Manage and maintain relevant Quality Technical Agreements (QTA) with supply chain partners Ensuring the correct GDP training programmes are rolled out to both new starters as well as existing employees within the business. Responsible for importation and product batch release into the local market (UK, RPi) Development and delivery of the departments business strategy in line with company’s overarching objectives Line management of QA/RA Associate with defined delegation of QA and RA responsibilities, keeping appropriate records of these delegated duties Work closely with the Celltrion global compliance teams (QA and RA) where joint responsibilities are identified Regulatory compliance lead in cross-functional projects e.g. product launches and supply chain model changes Work Experience Requirements: A minimum of a bachelor's degree in pharmacy, chemistry, or other related field, with a strong understanding of GMP and GDP principles A minimum of three years’ experience as an RP in a pharmaceutical environment Previously named as an RP/RPi on a WDA licence. Extensive pharmaceutical and logistics experience. Accomplished and experience in conducting internal audits and hosting regulatory inspections Core Competencies: Excellent knowledge of EU & UK GDP, GMP, and regulatory requirements for pharmaceutical products Excellent communication, organisational and leadership skills Ability to develop, implement and maintain Standard Operating Procedures (SOPs) and Quality Management Systems (QMS) In-depth knowledge of quality risk management principles and tools Confident in the ability to lead/direct both senior management and provide key regulatory advice that could impact the business. An individual who is comfortable in a fast-paced working environment and who can challenge, improve and develop more efficient working practices A person who enjoys collaborating with people in different teams as well as stakeholders in different countries across the wider business. Celltrion Values: Creativity Compliance with Principles The Spirit of Challenge The Pursuit to Be the World’s Best