CSV Lead

Blackfield Associates have collaborated with the lead developer of critical manufacturing management systems for advanced therapies in search for a full time remote CSV Lead. About the company: Our client company is founded by Cell and Gene Therapy (CGT) This company is creating a portfolio of software solutions such as electronic Batch Manufacturing Records (eBMR) They provide cell and gene therapy manufacturers with methods to scale their operations Their mission is to make medicine deliverable, available, and affordable. Responsibilities include: Develop, implement, and oversee the risk-based Computer System Validation (CSV) strategy for deploying the company’s main paper-based computer system Provide expert guidance to ensure business compliance with CSV standards, 21 CFR Part 11, and Eudralex Annex 11 regulatory requirements. Prepare documentation in alignment with the V-Model approach outlined in GAMP 5. Serve as a subject matter expert (SME) in CSV and data integrity for client projects, managing associated budgets effectively. Create, review, and execute validation lifecycle deliverables following the V-Model within GAMP 5 and GxP Good Practices. Lead investigations into validation-related non-conformances to identify and address root causes. Assist the project management team in maintaining and managing validation timelines. Advise on GxP compliance and industry best practices. Collaborate with stakeholders, including IT and Quality teams, to track progress and ensure successful completion of validation activities. Desired criteria: Hold a relevant degree in a scientific or technical discipline. Demonstrate the ability to clearly and concisely articulate system integrations. Possess experience with Quality Management Systems (QMS) in pharmaceutical and/or clinical environments. Exhibit a strong eagerness to learn continuously and embraces knowledge beyond a single area of expertise. Effectively explain and communicate complex system behaviours with clarity and precision. Excel in both collaborative team settings and independent work, maintaining strong organisational skills and self-motivation. Additional benefits: Join quarterly social events, whether it’s team-building exercises, dinners, or simply unwinding with a drink or two. Benefit from market-competitive salaries with regular pay reviews to recognize and reward great work. Receive top-of-the-line equipment for your home office setup to maximise productivity. If desired, able to utilise the London office near Oxford street Access to BUPA healthcare Pension matched to 3% and then an increase to 5% after probation completion Life insurance