Qualified Person

2 weeks ago

Abingdon, United Kingdom Replimune Full time

Replimune – Abingdon‑On‑Thames, England, United Kingdom Qualified Person We are looking for a Qualified Person (QP) to ensure each batch of product is manufactured, inspected and released in compliance with UK or EU regulations, Good Manufacturing Practice (GMP), and the relevant marketing authorisation or clinical trial authorisation. Job Summary The QP will be responsible for the full quality assurance chain, from batch record review to certification, and will work closely with manufacturing, quality control, and regulatory teams to safeguard product quality and patient safety. Responsibilities Ensure each batch is certified for release in compliance with Eudralex Volume 4, Annex 16, and local regulations. Maintain a calibration and audit register and record all certifications. Review batch records, QC data, cleaning logs, stability data, and supply‑chain information prior to release. Confirm that all manufacturing and quality control activities are performed in accordance with GMP principles. Ensure all sites involved in production, QC, distribution, and certification are licensed and compliant. Validate manufacturing and testing processes and confirm that acceptance criteria have been met. Verify that all materials, including active ingredients and excipients, meet regulatory specifications. Oversee post‑marketing monitoring, complaints, inspections and recalls, ensuring that any outstanding issues do not compromise certification. Lead investigations of quality defects and engage with the relevant departments to implement corrective and preventive actions. Co‑ordinate batch release for both commercial and clinical products intended for the EU and UK. Provide guidance on good documentation practice and support continuous improvement initiatives. Qualifications – Education B.A. or B.S. in a scientific discipline; M.S., Ph.D. or equivalent postgraduate qualification encouraged. Qualifications – Experience Qualified Person status under Article 49 of the 2001/83/EC regulation. Minimum of 2 years relevant pharmaceutical experience, preferably with steriles or Advanced Therapy Medicinal Products (ATMP). In‑depth knowledge of EU, UK GMP guidelines and continuous professional development of regulatory and industry updates. About Replimune Replimune Group, Inc. is headquartered in Woburn, MA and focuses on transforming cancer treatment through oncolytic immunotherapies. Our proprietary RPx platform delivers a dual local‑and‑systemic response, aiming to transform cancer care and create new therapies for patients worldwide. We are an Equal Opportunity Employer. #J-18808-Ljbffr

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