Senior Quality Control Scientist

This range is provided by Northreach. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range Direct message the job poster from Northreach Growing Biotech Start Ups effectively – Immunology / Cell & Gene Therapy- CAR-T / TCR/ NK Cells / Tregs / CMC / Quality Control / Analytical… Overview: This role provides Quality support to manufacturing operations and quality control, ensuring the production and testing of cell therapy products for clinical use within a shared GMP manufacturing centre. Key Responsibilities: Manage and perform QC duties to ensure compliance with GMP, GCP, HTA, and other regulatory requirements related to the manufacture and clinical trials of cellular therapies and ATMPs, including: Document control system Training system Change controls Corrective and preventative actions (CAPA) Complaint and recall handling Calibration and maintenance Qualification & validation Write and/or review GxP documents related to QC activities (e.g., SOPs, qualification/validation reports, and batch records) to ensure good documentation practices, data integrity, and regulatory compliance. Draft, review, and approve Quality and GxP-related documentation. Facilitate or perform risk assessments and investigations as required. Provide guidance to manufacturing and QC teams on Quality-related matters. Assess the quality and suitability of equipment, materials, and services for QC lab purposes. Monitor trends and the effectiveness of quality management systems, developing and producing KPIs and Quality Metrics. Inform Senior Management of significant quality-related matters or risks that could impact product quality, product release, or regulatory compliance. Organize and deliver QC-related training sessions. Provide general quality support for other business functions, including R&D, clinical trial sample testing, and process development teams. Act as a Subject Matter Expert (SME) for QC in alignment with relevant regulatory authority cGMP requirements. Follow current Good Manufacturing Practices (cGMP) in compliance with US, UK, EU, and other regulatory expectations. Recommend validation and qualification approaches, strategies, priorities, and resourcing needs for new projects or re-qualification cycles. Work within a matrix management structure, collaborating closely with internal and external teams, including suppliers and partners. Communicate and liaise with internal departments and external customers involved in qualification and validation activities to ensure efficiency and compliance with regulatory standards. If you are interested, then please apply with an up-to-date copy of your CV and I will be in touch shortly. Thanks Seniority level Mid-Senior level Employment type Full-time Job function Science #J-18808-Ljbffr