Associate Director
4 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. We are partnered with a globally market leading Biotech who seek to deliver truly innovative, life-changing therapies for our patients.
THE ROLE
The Associate Director - Site ǪA is responsible for managing and is accountable for all site related ǪA operations as part of the Site Leadership Team (SLT), providing comprehensive high level specialist expertise to both the ǪA team and key stakeholders in relation to this manufacturing site.
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.
Main Responsibilities
• Responsible for managing ǪA operations at a site level as defined in Ǫuality Agreements and as governed by GMP.
• Responsible for leading site and ǪA team adherence with the local or corporate ǪMS
• Assist in the development of the PǪS including establishing an eǪMS where relevant.
• 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.
• Manage and monitor the following elements of the PǪS relating to manufacture of cellular therapies including.
o document control system o quality risk management
o training system o qualification & validation
o change controls o leading Internal audits
o corrective and preventative actions (CAPA) o vendor qualification
o deviation & OOS reporting o batch record review prior to ǪP release
o manage Product Specification Files for
ATIMP’s o complaint and recall handling
• Develop, review, and approve Ǫuality and GxP related documentation.
Technical Requirements
• 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.
• Expert knowledge of GMP relating to sterile production, cleanrooms, aseptic technique, and hygienic requirements for sterile products
• 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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