Rebecca Rutter

Senior Consultant, GxPAssure

Rebecca Rutter is an experienced pharmaceutical quality, manufacturing and supply chain consultant with extensive leadership experience across advanced therapy medicinal products, biologics, sterile and aseptic manufacturing, clinical trials. She is an Eligible Qualified Person under the permanent provisions of Directives EC 2001/82 and EC 2001/83. Her further professional development has included Human Tissue Authority Designated Individual training, QP training (all aspects of the Study Guide), pharmaceutical project management leadership University of Cardiff and she is an IRCA Lead Auditor trainer.

Rebecca has held senior quality and manufacturing roles within global pharmaceutical, biotechnology, clinical services, consumer healthcare and SME environments. Her career has included leadership positions across cell and gene therapy manufacturing, global quality, category quality management, R&D site quality, clinical trials project management, site quality leadership, project management and business development.

Rebecca brings strong strategic and operational leadership capability, with experience supporting business strategy, change leadership, supply chain resilience and crisis response. She is a native English speaker, with conversational French and basic Italian language skills.

Key areas of expertise include:

• ATMP, biologics, sterile and aseptic manufacturing. 
• IMP and clinical trials set up execution and management.
• GMP facility set-up, site initiation and decommissioning.
• Inspection readiness assessment, remediation gap assessment and plan execution.
• Pharmaceutical quality systems, ICH Q10 and quality risk management.
• CAPA, root cause analysis, deviation management and complaints handling.
• Validation, qualification planning and technical transfer from R&D to GMP.
• Strategic quality system assessment, organisational change and regulatory readiness.
• Auditing, QP mentoring, coaching and leadership development.