Job Summary:

The Qualified Person (QP) must fulfil duties in compliance with Eudralex Volume 4, Annex 16, Certification by a Qualified Person and Batch Release.
The QP is responsible for ensuring that each individual batch of product has been manufactured and checked in compliance with laws in force in the UK or EU Member State where certification takes place, as applicable, in accordance with the requirements of Good Manufacturing Practice (GMP) and in compliance with the relevant marketing authorisation or clinical trial authorisation and product specification file, including clinical trial protocol, for a given product and associated trial.

This position is based in our Milton Park location and typically has minimally a 3 day on-site expectation. (hybrid)

• The QP must personally ensure that the following operational responsibilities are fulfilled prior to certification of a batch for release to market or for export in the EU and UK:
• Certification is permitted under the terms of the manufacturers importation authorisation.
• Any additional duties and requirements of national legislation are complied with.
• Certification is recorded in a register or equivalent
• Assessment of each batch for certification prior to release may include batch records, QC data, associated records/quality systems, production conditions, cleaning records, examination of the finished packs, results of any importation testing where relevant, stability, shipping data, audits, documents certifying the authorisation of a manufacturer, relevant regulatory and GMP requirements, verification of the supply chain and all other factors the QP is aware of as relevant to the quality of the batch.
• The QP shall ensure that products are manufactured and/or imported appropriately by applying manufacturing practice which ensures the quality of such medicinal products in order to safeguard the safety of the subject/patient and the reliability and robustness of clinical data.
• The QP shall ensure there are appropriate pharmaceutical quality systems in place as it relates to GMP, and should have a broad knowledge of pharmaceutical development and the clinical trial process.
• Specifically, the QP or a delegate shall confirm the following:
• All manufacturing and quality control activities have been conducted according to the principles of GMP
• The full supply chain for the product is documented and available to the QP
• All external audits have been performed as appropriate and are available
• All sites involved in the manufacture, quality control, distribution, and certification of the products are listed in the applicable application and are licensed as required
• All sites involved in the manufacture, quality control, distribution, and certification of the products are in compliance with the relevant application
• All manufacturing activities and testing activities are consistent with those described in the application
• The sources and specifications of the starting materials and packaging materials are in compliance with the applicable regulatory application
• The active pharmaceutical ingredient is manufactured and distributed according to GMP
• The active pharmaceutical ingredient has been imported as appropriate
• The excipients have been manufactured in accordance with requirements
• The TSE status of materials used are consistent with those described in the application
• All records are complete and endorsed by appropriate All required in-process controls and checks have been made
• All manufacturing and testing processes remain in the validated state
• Personnel are trained and qualified as appropriate
• The finished product quality control test data complies with the specification in the applicable regulatory application
• Any post-marketing commitments relating to manufacturing or testing have been addressed. Ongoing stability data continues to support certification
• The impact of any change to manufacturing or testing has been evaluated, and any additional checks/tests are complete
• All batch-specific investigations have been completed to a sufficient level to support certification
• Any ongoing complaints, investigations, or recalls do not negate the conditions for certification of each batch
• The required technical agreements are in place
• The self-inspection programme is active and current
• The appropriate arrangements for distribution and shipment are in place
• Where appropriate, safety features have been affixed

Other Responsibilities:

• Certification of the finished product batch signifying that the batch is in compliance with GMP and the requirements of its marketing authorisation or clinical trial authorisation and product specification file.
• Confirmation that the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation product specification file as applicable and the principles and guidelines of GMP.
• Take a lead role in any quality defects as referred to in Chapter 8 of Eudralex, Volume 4, Part I (Complaints and Product Recall) and Part IV (Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products)
• Oversee batch review of Replimune clinical and commercial products for use in the EU and UK.
• Execute batch disposition of Replimune clinical and commercial products for release in the EU and UK.
• Assess applicable deviations, quality defects, change controls, complaints, product labels, as appropriate.
• Provide support to the company and its staff to drive continual

• Education:
• B.A or B.S. degree in an appropriate scientific M.S., Ph.D. or other post¬ graduate degree is encouraged.
• Required Experience:
• • Eligible as Qualified Person satisfying the provisions of Article 49 of 2001/83/EC 06 November 2001.
• Maintain up to date regulatory and industry knowledge through program of Continuous Professional Development.
Experience and Skill Requirements:
• Knowledge of EU and UK regulations and guidelines regarding GMPs.
• Sufficient industry experience no less than two (2) years of experience within relevant pharmaceutical fields.
• Experience with steriles required and Advanced Therapy Medicinal Products (ATMP) preferred.