MA MSc MBA CChem FRSC
Provision of quality system and regulatory advice to the pharmaceutical industry, with particular interest in the interface between development projects and manufacturing and supply chain.
Highly experienced in international operations in the pharmaceutical industry, with twenty years in “big pharma” and over fifteen years as an independent consultant working with clients in Europe, the USA, Australia, India and Japan. I offer strong strategic and operational management experience combined with excellent communication skills and the experience of working both in international operations and in an R&D environment.
I am eligible to be a QP under the permanent provisions of both 2001/83/EC and 2001/20/EC with particular expertise in IMPs and in solid oral products.
Coming from an analytical chemistry background I have technical expertise combined with a general knowledge of a wide range of business systems obtained from successfully completing a Masters degree in Business Administration (MBA).
I have expert knowledge of Quality Management Systems and the principles of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Quality Assurance of both marketed products and those in clinical and pre-clinical development.
I have undergone specific training in quality systems auditing and ICHQ7 compliance.
I am experienced in assessing and managing outsourced services and supply chains (including storage and distribution), managing new product introductions and product transfers, conducting GMP and Quality Systems audits and interpreting international regulatory requirements.
I have an international outlook and speak and write Spanish fluently. I also have a working knowledge of French and German. English is my first language.