Quality Manager CMO

Randstad Business Solutions ,
Dublin, Suffolk
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Overview

Our client is one of the largest pharmaceutical companies in the world by revenue. The company continues its transformation into an agile and innovative global pharmaceutical leader, serving the needs of patients and physicians worldwide. Our client draws on the expertise of its world-class people, equipment and systems to meet the challenges of competing in our leading-edge markets. They aspire to be a dynamic R&D organisation that thinks, acts and interacts with the external world like no other. They plan to achieve this through an intense focus on the best science for those therapies that can deliver true innovation for patients. Role Description: The Quality CMO team is accountable for oversight of Biologics product manufactured at CMOs on behalf of the client. The scope includes Drug Substance, Drug product and Finished Drug Product CMOs. The team will work with our external CMO partners and internal Quality teams. In addition, this function works closely with External Supply, Supply Planning, Technical support and any stakeholders involved in external supply. Key Accountabilities: you will be the Quality contact for CMO(s) maintaining oversight at those CMOs for Quality related topics You will be the Quality representative on the External Supply team and will work collaboratively with the cross functional team and CMO to facilitate supply of product to our patients according to the client's SOPs and GMP standards You will prepare for and attend relevant CMO governance meetings and internal client meetings You will be required to resolves quality related topics and escalate where further input is required You will be the Quality contact/approver for Quality documents, for example, change controls, deviations, CAPAs, validation documents related to CMOs and you will be the Quality approver for CTL documents. You will maintain and improve CMO quality metrics that incorporate continuous improvement methodologies and where necessary, you will support internal audits and Health Authority inspections as required. You will review and approval of CMO documents Provide evaluation of CMO's Quality Management Systems to ensure appropriate level and content of reporting, including technical evaluation of quality system reports You will work in collaboration with the Disposition team, Quality teams and cross functionally with external supply, planning, technical and other stakeholders including CMO partners. Key Skills Required Thorough understanding of quality systems and cGMPs. Experience conducting audits and/or involvement in preparation for Health Authority inspections. 8 years' experience working in manufacturing and/or Quality to support the manufacturing of biologic products. Strong technical/Quality background with specific experience in Biologics manufacture. Manufacturing site experience and CMO oversight experience would be valuable. Interpersonal skills and communication skills to interact with CMO partners and other functions. Must be able to prioritize in a busy environment. Must be available to travel -approx 20% (domestic and international). This role is offered on a full time basis, manufacturing and / or pharmaceutical experience is essential and you can work from home one day per week. Apply now to be considered for this role. Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003

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