Stuttgart, Baden-Württemberg, Germany
Global Head of Quality Healthcare @medmix, a swiss-based company supplying precision delivery devices to customers for dental, drug delivery and surgery applications. Key competencies: refreshing, global harmonization and digitalization of QM-Systems, growing talent and building high performing teams and a very broad knowledge on al quality aspects from product development to distribution. Product range: medical devices, pharmaceuticals, combination products and clinical trial materials Assigned functions: EU-Qualified Person, Wholesale Responsible Person, PRRC, Management Representative, Vigilance Officer,...
Budget, functional and disciplinary oversight over >100 quality people working in medical device / combination product development and manufacturing QMS. Responsible to get 6 sites aligned on quality standards, systems and software to accommodate 3 different business units in 3 continents, including injection molding, component manufacturing, combination products and medical device manufacturing class 1 to class 2b.
Securing the compliance of Haselmeier operations to current standards of GMP, ISO13485 and 21 CFR 820 for medical devices and drug device combination products, including the pharmaceutical packaging operations at the Haselmeier Buchen / Germany site
- digitalization of the entire QMS system from paper to digital in 2 years - upgrade of the QMS to ISO13485, 21 CFR part 4 and part 820 and GMP standards - establishing combination product manufacturing standards and manufacturing authorization for combination products - primary point of contact for authorities and Notified Body - leading a team of 40 quality people across 4 sites in 3 countries
- Leading the group Quality Governance team - Responsible to provide input and guidance on Celesio group-wide initiatives related to quality aspects - Coordinating Quality initiatives within the Celesio network and heading quality workgroups as multi-national initiatives - Support of country organisations in implementation of GxP and ISO9001 standards - Definition and collection of quality related KPI, including periodic trending and feedback to the upper management and Quality Council
Site QA head Responsible for Clinical Supplies quality systems and EU batch release, Pharmacovigilance officer The Catalent Schorndorf Clinical supplies group has currently approx. 100 employees, 15 of them in QA