Technical Project Manager (m/f)

REFERENZNUMMER:

331231/1

IHRE AUFGABEN:

-Lead and manage the development of leading-edge next generation Drug Delivery medical devices throughout the execution cycle from requirements through to product filing and market launch support
-Lead cross-functional and supplier activities to ensure delivery of product functionality, quality, and schedule within budget and with compliance to quality, regulatory and customer requirements
-Provide project plan, project risk log, action trackers and meeting minutes as well as dashboards for management reviews
-Manage global medical device development projects to successful launch, ranging from class I to sterile class III, standalone CE marked devices and combination drug device products
-Execute several medical device development projects in accordance with global IT/Quality standards, and industry standards (GMAP 5, EU Annex 11, 21 CFR 11) within the medical device engineering department

IHRE QUALIFIKATIONEN:

-Master or PhD in Pharma, Life Sciences, Chemical Engineering
-Excellent knowledge in computer system validation, project management and analytical testing and method development
-Combination drug device product
-Strong knowledge in contracts and budget management, GAMP 5 , industrialisation and manufacturing and medical device design and development
-Experience in leading project teams
-Fluency in English

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist