Angestellt, Head of IT PMO, INNIO Jenbacher GmbH & Co OG
An information systems project and program manager with more than 30 years of international experience in the pharmaceuticals and chemicals industries, holding certifications in several project management methodologies, quality management system auditing, information security management systems and computerized systems validation. I am a project and program management practitioner, a validation and compliance consultant, a business analyst, a team leader, coach and mentor, a teacher and an author. My professional certifications include the PMI PMP® (Project Management Professional 2009-2018), Quality Management Auditor (TÜV-QM-Auditor for ISO 9001:2015), Computerized Systems Validation expert (CSV-Beauftragter) and I am a trainer at Concept Heidelberg (Course CV 20: GAMP 5 praktisch angewendet). If there is anything else you would like to know, just ask :-)
Professional experience for James Greene
Current 2 years and 8 months, since Nov 2020
Head of IT PMO
INNIO Jenbacher GmbH & Co OG
Head of the IT Project Management Office, responsible for the "demand to project" approval process, monitoring and controlling project manager performance, providing PM training and managing our strategic portfolio management system. Also supporting our ISO 27001 and Enterprise Risk Management initiatives.
5 years and 1 month, Oct 2015 - Oct 2020
Senior Manager / PartnerSignificon AG
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).
1 year and 3 months, Jul 2014 - Sep 2015
Director Business Development & Operations, Germany
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).
1 year and 5 months, Feb 2013 - Jun 2014
Senior Project & Program Manager
D-ploy (Schweiz) GmbH
Team Leader, Account Manager
10 months, Apr 2012 - Jan 2013
DHC Dr. Herterich & Consultants
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.
3 years and 7 months, Sep 2008 - Mar 2012
Manager, Computerized Systems ValidationArcondis Group
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.
2 years and 2 months, Jul 2006 - Aug 2008
IMS Health/M&H Informatics AG
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.
2 years and 1 month, Jun 2004 - Jun 2006
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.
4 years and 4 months, Feb 2000 - May 2004
General Managerinnobit ag
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.
5 years and 10 months, Jul 1996 - Apr 2002
Greene Informatics Consulting
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.
8 years and 1 month, Jan 1992 - Jan 2000
F. Hoffmann-La Roche AG
2 years and 1 month, Jan 1990 - Jan 1992
Hoffmann-La Roche AG
4 years and 1 month, Jan 1986 - Jan 1990
Educational background for James Greene
3 years and 5 months, Sep 1983 - Jan 1987
California Lutheran University
Computer Science Mathematics Accounting Communications / Radio