James Greene

Significon provides consulting services, founded in the experience, knowledge and motivation of our staff. We optimize our customer’s processes and organization through a combination of process and compliance expertise, across both the strategic and the operational realm. Our focus is on the logistic processes in the Life Science industries and the implementation of these processes in the management systems (e.g. SAP).

Rescop (Regulatory System Compliance Partners) liefert innovative Lösungen und Dienstleistungen für GxP-Compliance in regulierten Industrien. Wir bieten eine Software-Lösung für die papierlose Inspektionsbereitschaft sowie Qualitäts- und Prozessmanagement-Beratung. Ich wurde engagiert, um die Expansion von Rescop in den deutschsprachigen Raum zu führen. Meine Rolle beinhaltet sowohl Business Development (Pre-Sales und Vertrieb bis zur Auslieferung) auch Operations (Geschäftsführung des Rescop GmbH).

Team Leader, Account Manager

Senior Manager, Compliance Competence Center. Program manager for the IT Infrastructure Integration following a corporate acquisition, followed by the planning of the IT Infrastructure "carve out" as part of a corporate divestment.

Manager, Deputy Head of the CSV (Computerized Systems Validation) group, responsible for the Validation service team. Projects include GxP Compliance Checks, IT Security Checks, Supplier Audits, Computerized Systems Validation support, Technical Migration Project and Program Management.

Senior Consultant and Project Manager at M&H Informatics/IMS Heath. Projects included managing the development of a series of enhancements and interfaces to the clinical trial management system of an international pharmaceuticals company (Project budget 575 KUSD). Another project involved leading a a 10-man team performing an in-place technical migration procedure with CSV compliant documentation on several hundred end-user workstations (Budget 250 KUSD) on-site in the USA.

Group leader for the redtoo team providing consulting and services to the global public key infrastructure (PKI) organisation in an international pharmaceutical company. Customer projects include software package engineering for electronic software distribution with enteo's NetInstall and quality assurance testing of PKI-enabled applications on a standardized Windows desktop environment, and basic and project management training for customers in the pharmaceuticals industry.

Managing Director, Project and Quality Management & Consulting. Customer projects included conception and implementation of standardized desktop environments including electronic software distribution with NetInstall or (BrainWare) Columbus for various industries, concepts for disaster avoidance and recovery for desktop environments, a retrospective validation of a desktop system implementation, design of Internet- and Intranet-based information systems, etc.

Owner. Projects included systems consulting and procurement, local-area network design and implementation, software development and Web page design and maintenance. Customers included medical device manufacturer, a private high school and a local hand-worker. Development and support of several freeware and shareware programs, including Auto-Play, Plot2EMF, NameDate and CBText.

Computer Science Mathematics Accounting Communications / Radio