Ian K. Sykes

Before establishing IKSA, Ian Sykes was the original founder and Director of Pharmaceutical Consultancy Services vof (active since 1990). His previous experience includes: Chief Microbiologist for Fisons Pharmaceutical,  Area Medicines Inspector for the MHRA (formerly MCA and DHSS), founding partner of David Begg Associates and Director of Pharmaceutical Manufacturing for Centocor, the Netherlands.

An experienced Quality Assurance Specialist/Manager with a proven track record of success, specializing in pharmaceutical and general healthcare products, capable of providing high-level strategic and technical advice on Quality System Management and implementation, to consistently improve business quality performance and compliance to MHRA, EU, FDA and WHO requirements.

A strong, goal oriented and pro-active leader, providing coaching, training and mentoring to teams of professionals working together to achieve quality targets and customer objectives. He has many years’ experience in quality management across the entire pharmaceutical product life cycle from early development through to commercial manufacture both of Drug Products as well as APIs. In addition, as an experienced ex-regulator he has performed GMP inspections on a worldwide basis at pharmaceutical and API manufacturing facilities, including small molecules and biologicals.

He is an acknowledged Subject Matter Expert in GMP of vaccines and biotechnology derived products, providing technical and strategic consultancy on all CMC issues to a range of companies and NGOs.