Senior Manager Qualified Person UK Job in United Kingdom Recruiting by Skills Alliance

Position Summary:Acting as Qualified Person (QP), in accordance with Article 51 of Directive 2001/83/EC and the requirements laid down in the UK GMP. Additionally ensuring that the requirements of the granted license issued by MHRA are met for ensuring that each individual batch has been released and checked in compliance with GMP, the relevant marketing authorization (MA) or clinical trial authorization (CTA), product specification file (PSF) and/or quality technical agreement (QTA), the laws in force in the United Kingdom, and the company’s procedures. Supervising the company’s operations to allow for product import, release, and wholesale distribution in GB for safe trading of medicinal products. The QP is authorized to issue directives within scope of the Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) responsibilities.Key Responsibilities Include:Interacts with the MHRA Agency for Medicinal Products for all quality related topics.Independent decision to release or reject a batch of investigational and commercial medicinal products compliant with the UK GMP and GDP requirements, MA, CTA, PSF, and QTA as applicable.Ensuring that the finished medicinal product batch has undergone all tests or checks necessary to ensure the quality of medicinal products is in accordance with the requirements of the MA unless an MRA or similar agreement is in place between the UK and the exporting country.Ensuring that handling and distribution of medicinal products are in accordance with regulatory requirements, GMP and the company’s procedures.Ensuring that any additional requirements imposed on certain products by national legislation are adhered to.Supporting identification of gaps and risks, its remediation and implementation of continuous improvement opportunities in the company’s quality management system with respect to UK requirements.Ensuring escalation of GMDP issues including critical complaints, potential counterfeits, potential recalls, critical product quality issues and HA issues related to product compliance and quality.Hosting and preparation of audits and inspections, including support of the Contract Service Providers (CSP) audit program.Performing audits at the company’s CSPs.Supporting establishment and maintenance of quality technical agreements with customers and suppliers.Provide quality oversight of CSPs the company’s responsibility.Cross-functional collaboration with Regulatory, Supply Chain, Technical Operations, Business Development to support various projects.Managing the local and participating in the regional Quality Management Review (QMR).Involvement in resolving complaints, deviations, change controls related to the company’s medicinal products.Supporting and monitoring corrective and preventive actions (CAPAs) as applicable.Ensuring an effective procedure is in place for medicinal product recall and testing this system periodically.Deciding on potential recall operations in the UK.Keeping appropriate records of any delegated duties.Stays abreast of new and revised governmental/industry/company regulations and ensure the company’s QMS and processes meet the requirement.Keeps up to date with regulatory developments impacting on the company’s activities.Education, Registration & Certification:Degree in Life SciencesQP registration in the UKMembership of an appropriate professional body recognized by the MHRAExperience: 8+ years of industry experience. Skills, Knowledge & Abilities:Involvement in activities such as manufacturing of medicinal products (GMP) or the wholesale of medicinal products (GDP)Knowledge of medicinal product legislation and corresponding guidance to ensure that every imported batch meets all the applicable requirements as set forth in Directive 2001/83/EC, Directive 2001/82/EC, Directive 2001/20/EC and Statutory Instruments (SI) 2012 1916 and SI 2004 1031 and the applicable guidelines on Good Manufacturing Practice (GMP) on Good Distribution Practice (GDP) of Medicinal Products for Human.Travel Requirements:Up to 15% travel expected. Company Background:We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.