Our growing Bio-pharmaceutical client who are seeking to deliver truly innovative, life-changing therapies for their patients are looking for someone to fill the role of QA Manager. Their vision as a company is to be a major global biopharmaceutical player bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases.
The main purpose of this position will be to provide Quality support for the manufacturing operations. This position offers an excellent opportunity for an innovative and pragmatic quality professional to contribute to developing a risk based quality system which supports the development of a growing pipeline of assets in an exciting and highly dynamic environment focused on developing cutting-edge cellular therapies.
- Assist in the development of the PQS including establishing an eQMS
- Perform routine QA duties to ensure manufacturing and testing activities comply with the local GMP facility processes where products are manufactured
- Provide quality support to ensure starting materials are procured, tested and imported as required according to UK HTA requirements
- Manage and monitor the following elements of the PQS relating to manufacture of cellular therapies including; Document control system, Change controls, Corrective and preventative actions (CAPA), Deviation & OOS reporting, Quality risk management, Qualification & validation, Internal audits, Vendor qualification, Batch record review prior to QP release and Product specification files for ATIMP’s
- Draft, review and approve Quality and GxP related documentation
- Trend and report quality performance metrics from the PQS
- Inform Head of Quality and Senior Management of significant quality related matters or risks that could impact patient safety, product quality, product release or regulatory compliance
- Provide Quality support for R&D processes in state-of-the-art R&D laboratories to ensure best laboratory and data integrity practices
- The role may need to provide general support for quality related clinical operations under GCP
- Organize training of quality system and deliver basic GMP training
Essential Qualifications & Experience
- Min 5+ years’ experience in GMP manufacturing environment (in particular small scale e.g. ATMP’s, clinical trials or individualised patient products is desired)
- Min 3+ years’ experience in a Quality Assurance related role
- University degree in a biological science, chemistry or equivalent
- Experience in providing scientifically sound, risk based and pragmatic quality advice to manufacturing and quality control functions
- Extensive experience writing and reviewing GxP documents (including SOP’s, qualification/validation reports and batch records prior to QP review) to ensure good documentation, data integrity, essential GxP, quality and regulatory requirements are met.
- Demonstrated experience in developing a PQS especially involving an eQMS
- A good working knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products
- Exemplary attention to detail and record keeping demonstrating good documentation practices
- Excellent interpersonal and English language communication skills (written and verbal)
- Good working knowledge of using Microsoft office programs
Desired Skills and Experience
- A working knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
- A working knowledge of Tissues and Cells Directive and HTA requirements
- Experience of electronic Quality Management Systems
- Experience of quality aspects relating to GCP
- Basic understanding of immunology
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
Analytical Validation Manager - Permanent - London Brilliant Opportunity in central London to support a rapidly growing Gene Therapy company with their transition into commercial manufacturing.
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