Personal Background

Dr. rer. nat. Jaime Guardiola has over 40 years of industrial experience in production,
development, regulatory affairs, quality control and quality management. He gained his
experience at Salvia/Boehringer Mannheim (later Clintec – a Baxter USA /Nestlé joint venture) and
at B. Braun Melsungen AG in Melsungen, where he was ultimately Production Manager at the main
plant.
From 2001 to 2010, Dr. Jaime Guardiola was Technical Manager in aligna AG (formerly
PlasmaSelect AG) responsible for all pharmaceutical issues, as Qualified Person, QPPV and other
RA responsibilities, as well as several years as Managing Director of the subsidiary TheraSelect
GmbH.
From 2011 until his official retirement at the end of 2014, he was employed by AlleMan Pharma
GmbH, where he performed practically the same tasks as in his former company.
Since the beginning of 2015, he has been fully dedicated to management consulting with activities
such as interim management, external QP, production line planning, technology transfer outside
EU, project management and conducting audits for pharmaceutical companies as a subcontractor.

Dr. Guardiola’s business activities and projects that he has led include:
– Development of product families ready for approval, some of which are patented,
– Qualified person, also legal responsible person for narcotics and PRRC as interim manager in
various German companies,
– Design and planning of complete production lines in Germany and in the Czech Republic, India,
Indonesia, Turkey and Morocco,
– Management of several plants in a group of companies,
– takeover of production facilities, restructuring, new investments,
– production-related and regulatory mergers or integration projects
– Establishment and management of a regulatory organization in Central Europe for
pharmaceutical products, medical devices and dietetic foods,
Due to these diverse activities and projects, Dr. Guardiola is an expert in all aspects of project
management.
He has published several articles in the field of “Quality and Efficiency” and has given seminars on
this subject.
He was a member of the DIN Committee on Medicine (German Institute for Standardization) for
several years.