Lugano, Ticino, Switzerland
Experienced Technical Project Director with a demonstrated history of working in the pharmaceuticals industry combining deep Quality and Engineering competence to drive for challenges and business consolidation. Strong business development professional skilled and attitude in Pharmaceutics, Medical Device and Consumer Health Management, U.S. Food and Drug Administration (FDA), Regulatory Affairs, and U.S. Title 21 CFR Part 11 Regulation as well as EMEA and Asia Pacific regulations. Excellent people developer and performance team builder.
OTC Medicinal NPD/SMP Project Portfolio Director within the EMEA Product and Program Management team, effective August 1st 2015. Implementing the best practice in Project Management for New Product Development/launches and Support Marketed Product into consolidated process within the J&J Consumer Supply Chain organization, located in Zug, Switzerland.
Program implementation for harmonization and alignment of quality and business processes with J&J Standards . Processes and organization redesign. Interim for Technical Services Director and Engineering Director.
I am responsible for seven different groups as follows: - Tech Services Facility & Utilities; - Site Engineering and process improvements; - Site Project Management - Qualification, Commissioning and Calibration; - Process & Cleaning Validation; - New product introduction and Site to Site Technical Transfer; - Site Technical Regulatory