Nick Thomas

Management of QA teams establishing and maintaining quality standards for all the GMP and GLP departments within Crucell Leiden. • Responsible for quality leadership and strategy in Leiden • Transforming the organisation and culture • Directing interactions within Quality Assurance, within Crucell, and with other J&J companies • Representing Crucell during audits by external agencies • Delivering Management Review and effective Quality Metrics • Ensuring GLP facilities, SOPs, and studies are appropria

Management of GCP, GLP and GMP Equipment/Facility/Utility Qualification and Computer System Validation Quality Assurance: • Delivering effective and efficient Equipment/Facility/Utility/Computer System QA oversight • Responsible for the Qualification/Validation QA function within USA, Germany and Singapore • Directing interactions within Quality Assurance, within the division, and other Abbott divisions • Maintaining awareness of current and future Qualification & Validation requirements and expectations

Management of Quality Assurance Process Improvement team to develop GCP, GLP and GMP compliant Quality Systems: • Liaising with functional leadership to identify, facilitate and implement quality and business improvements • Implementation of Lean Six Sigma methodologies and portfolio management • Ensuring an effective Quality Metrics and Management Review program • Responsible for the GMP CAPA program

Management of Quality Assurance Systems team to develop GCP, GLP and GMP compliant Quality Systems in Europe: • Designing and implementing new and improved Quality Systems • Collecting Quality Metrics data and presenting and participating in quarterly Management Review • Delivering an effective Software QA program • Managing the CAPA program for Research and Development operations • Supplying GCP, GLP and GMP bi-lingual (German and English) Quality System document management

Management of QA Compliance team to assure compliance of GMP, GLP and GCP operations in Europe: • Planning and conducting GMP self inspections and CRO audits • Designing the CAPA program and implementing a Non-Medical complaints system • Responsible for GLP QA programme in Abbott Germany and Inspections in European GLP Test Facilities • Ensuring an appropriate GCP and Pharmacovigilance audit program • Implementing Quality Metrics data and participating in quarterly GxP Management Review • Management of Regu

Assuring Good Manufacturing Practice compliance of Clinical Trials Supplies: • Planning and conducting GMP self inspections and CRO audits • Designing and implementing new and improved Quality Systems • Representing Abbott during audits by external agencies

Assuring Good Manufacturing Practice compliance of Clinical Trials Supplies and Specials: Supervising, training and appraising new and experienced QA staff Releasing manufactured and packaged Clinical Trials Supplies and Specials Maintaining quality standards and timelines, designing and implementing Quality Systems Representing Abbott during audits by external agencies Auditing in-house and contract facilities

Assuring Good Laboratory Practice compliance of studies: Auditing protocols, standard operating procedures, raw data, reports and in-life phases of studies Conducting facility inspections, in-house and of sub-contractors and suppliers Assisting and deputising for Quality Assurance team leader Training Quality Assurance staff