Marcel B. Email & Phone Number

With an innovative mindset, responsible for implementation of a wide range of effective QA processes with focus on the internal customer. My knowledge and experience in QA and Business Administration are important competencies in redesign of business processes to be efficient with a minimum of bureaucratic 'waste".Currently working as Senior QA Manager at Astellas Pharma Inc. with more than 20 year of experience in Quality Assurance at global Medical Device and Pharmaceutical manufacturing plants within the framework of international regulations for EU, US and Japan.Contributed to the successful development, market approval and manufacturing of medical devices, solid oral dosage forms and wireless communication devices. Besides a wide range of operational QA activities, I have been leading implementation projects for Lean Validation, System Development Life Cycle management, Change Control, Risk Management, Document Management, Process Management and Data Integrity by Design.These projects all delivered innovative QA concepts, meeting the highest regulatory requirements while maintaining the efficiency and agility that a modern pharmaceutical manufacturing plant needs.Specialties: Project Leadership, Quality Assurance, Quality Engineering, Quality Systems, GMP, Auditing, Quality Risk Management, Lean 6-Sigma, Statistics, Data Integrity, Change Control, Qualification and Validation, Process Management.