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My client are seen as one of the top ten global biotechnology companies to watch in 2020, who have real focus on the development and commercialisation of unique gene therapies to change lives. They have a strong pipeline with two clinical trials ongoing and two more coming in 2020 which allows them to have a real chance to change the lives of patients by providing directed gene therapy as a life long and potentially curative treatment. This company are fully invested into their employees by providing professional development, flexible work/life balance and a chance to make a real-world impact.
This role will give you the freedom to manage and be responsible for QA oversight of outsourced GXP activities. Including, the approval and monitoring of GMP & GxP providers/suppliers where you will be the primary point of contact. You will act as the interface between third parties, suppliers, warehousing, shipping etc where you will implement new strategies to ensure continuous improvement.
You will need to co-ordinate and manage audits of GMP suppliers and GXP service providers in accordance with the Annual Audit Schedule. While also, managing the third-party Quality Incident Evaluation (QIE) system
In this role, you will need to approve Quality &Technical Agreements (QTAs), third party Change Notifications.
Furthermore, you will act as the interface between third parties, suppliers, warehousing, shipping etc were you will implement new strategies to ensure continuous improvement. Reviewing and approving temperature-controlled shipments, while maintaining the Approved Supplier List (ASL)
Must be able to manage the oversight of third-party warehousing activities of shipping and distribution tasks.
Must Educated to degree level or equivalent with a pharmaceutical related or biotech related degree.
Prior experience in the pharmaceutical/biotechnology industry, minimum 5- 7 years QA experience of which at least 4 must be working with third parties/ outsourced providers.
Previous experience with external auditing GMP suppliers and GxP service providers
If you are looking to share an ambition of excellence and you are looking for a high paced work environment, this could be a perfect fit for you.