Quality and Risk
3 weeks ago
Northreach is a dynamic recruitment agency that connects businesses with top talent in cell & gene therapy. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth. The role has responsibility for building and managing a small team of ǪA professionals and creating a strong quality culture on the site.
The individual will deputise for the Senior Director, ǪA as required and assist in developing and implementing quality strategy for site and for other areas.
Responsible for leading site and ǪA team adherence with the local or corporate ǪMS
• Defines and develops new quality processes, policies and data management including setting up quality standards and metrics ensuring they are met.
• Oversees and performs complex ǪA activities involving evaluating and reviewing processes to ensure manufacturing, testing and clinical trials activities comply with GMP, GCP, HTA and other regulatory requirements relating to manufacture and clinical trials for cellular therapies and AT(I)MPs including.
• Identifies and communicates significant quality related matters or risks that could have major impact on product quality, product release or regulatory compliance that affect the site.
• ATIMP’s o complaint and recall handling
• Extensive experience writing and reviewing GxP documents (including SOP’s, qualification/validation reports and batch records prior to ǪP review) to ensure good documentation, data integrity, essential GxP, quality and regulatory requirements are met.
• Extensive knowledge of regulatory requirements or processes that specifically apply for the
manufacture and/or testing of cell therapy products and/or ATMP’s.
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