Nigel currently leads all compliance and inspection readiness activities for Sanofi's combination products business, based in Normandy, France. Prior to Sanofi Nigel has a 30+ year body of experience in quality and compliance across the industry, including tenures at DHL Life Sciences (helping to set up the life sciences logistics unit), Roche, MSD, AstraZeneca and Norgine amongst others.
Monitor complex set of inputs including current environment, industry trends and emerging regulations in order to anticipate potential risks and the need for changes and influence site and global management directions regarding new or revised strategic initiatives. Analyze results of quality system assessments conducted within the network and align strategic improvements with site and global stakeholders.
Developing people, developing processes, effective best practice compliance, root and branch company reviews, gap assessments, organisational fitness assessments, regulatory strategies and development of growth strategies.
Pharmaceutical: focus on product quality and patient needs to develop pragmatic quality systems based on mitigating risk.