Senior Quality Assurance Specialist

Job Description

Senior QA Specialist – FTC

We are currently looking for a Senior QA Specialist for a leading biotechnology company in Central London for a long-term FTC. The successful candidate will be responsible for GMP oversight of clinical-stage manufacturing and testing of advanced therapy products. This includes managing quality systems, supporting continuous improvement, and overseeing outsourced activities.

Key Responsibilities

• Manage quality processes such as batch review, deviations, change control, CAPA, and documentation
• Maintain and improve quality systems, including risk management, audits, training, and vendor oversight
• Ensure compliance with GMP and regulatory requirements through risk-based assessments
• Support supplier qualification and monitor outsourced manufacturing activities
• Produce and review quality documentation and performance metrics
• Provide quality guidance across teams and support cross-functional projects
• Promote a strong quality and continuous improvement culture

Requirements

• Experience in pharmaceutical QA within GMP environments (e.g. biologics or advanced therapies)
• Knowledge of UK/EU GMP and clinical-stage product requirements
• Strong attention to detail, organisation, and communication skills
• Experience with quality systems, risk management, and compliance
• Degree in a relevant scientific discipline

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