I want to pivot my career and pursue a role in AWS, MS Dynamics, and GCP architectural management.
Aktualisiert am 17.11.2023
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 04.12.2023
Verfügbar zu: 100%
davon vor Ort: 100%
IT Management
IT Project Management
Digital Transformation Expert
Solution Architect
Integration Architect
Requirements Analysis & Management
Technical Leadership
Cross-functional Team Management
Stakeholders Management
Analytical & Problem-Solving Skills
Result Orientation
Quality Management Integration
Risk Management
Change Management
Continuos Improvement
Cloud GxP Compliance
Microsoft365 & Office365 (Admin)
GxP and GMAP5
English
Business Proficiency / Fluent
Italian
Muttersprache
German
Fortgeschritten
French
Competent

Einsatzorte

Schweiz
möglich

Projekte

5 Jahre 5 Monate
2018-06 - 2023-10

Provide high-quality solutions

Innovation & Solution Manager
Innovation & Solution Manager

Provide high-quality solutions for the Life Science industry. Ensure alignment of IT initiatives and business/manufacturing objectives (BIA) to integrate Digital Transformation strategies. Engaged in management as a Squad Leader, Project Manager, Program Manager, Agile and SCRUM practitioner. Mastering projects delivery using Waterfall (V-Model) and Agile (SCRUM, Kanban) methodologies. Provide effective IT solutions for Project and Program Management Tools to increase quality of service. 

  • Incyte ? CSV of SAP s/4HANA. Lonza ? Digital Transformation project; paperless systems implementation and strategies KNEAT. ServiceNow SLAs & Config. PlanView implementation. 
  • Takeda ? Model for Efficiency of Validation software evaluation. 
  • Merck ? New biotech facility systems implementation and digitalization. 
  • Incyte ? Digital Transformation project; paperless systems implementation and strategies. 
  • GXP Consulting ? Digital Transformation strategy implementation. 
  • CSL Behring ? FS Process and FS Diagrams for MES implementation. 
  • Bracco CH ? CSV strategy analysis. 
  • AAA ? consulting for QA IT documentation. 
  • iCube ? Digital Transformation QMS implementation for suppliers to life science. 
  • Valgenesis ? partnership program?s creation and strategist, paperless software platform implementation project management, and pre-sales activities (Platform Technical presentation, Requirement analysis for best solution architecture).

GXP CONSULTING (LIFE SCIENCES)
Switzerland
2 Jahre 7 Monate
2015-11 - 2018-05

Deliver IT project management solutions

Senior Consultant & Project Manager
Senior Consultant & Project Manager

Deliver IT project management solutions across the Life Sciences value chain and contribute to the company?s professional image through the provision of top-class consultancy services. Ensure alignment of IT initiatives and business objectives (BIA) to integrate Digital Transformation strategies. Lead multiple, complex projects (time&material, and resources) aimed at developing better products, services and manufacturing processes. Focus on IT/ IS systems, QMS, CSV development, quality management, and research and development. Facilitate delivery of projects using Waterfall (V-Model) and Agile (SCRUM, Kanban) methodologies. 

  • Thermofisher ? Implemented quality management strategy for pharmaceutical manufacturing devices. 
  • Swisscom ? Led the requirement definition for GxP compliance of Cloud (SaaS, PaaS, IaaS) services recommendations.
  • Medtronic ? QMS development & Process gap analysis.
  • Quotient ? Led implementation of the CSV strategy during the development of a medical device for diagnostic transfusion.

ALTRAN AG (LIFE SCIENCES)
Switzerland
1 Jahr 10 Monate
2014-03 - 2015-12

Championed the post-sale planning

Sr.Software Consultant & PM
Sr.Software Consultant & PM

Championed the post-sale planning and implementation of software applications. Led successful QMS System integration from beginning to end, including resources, project scoping, reporting and change management. Effectively managed financial and Pilgrim project resources, ensuring accurate resource billing within budget. Collaborated with customers on and off-site to assess requirements on systems including SaaS, COTS, and databases.

  • VelaDignostics ? Pilgrim QMS project management for system implementation.
  • Stallergenes - Pilgrim QMS project management for system implementation.
  • Vitalograph ? Pilgrim QMS project management for system implementation.

PILGRIM QUALITY SOLUTIONS EMEA (LIFE SCIENCE)
Switzerland
1 Jahr 9 Monate
2012-06 - 2014-02

Utilised technical expertise and analytical skills

IT Quality Validation Manager
IT Quality Validation Manager

Utilised technical expertise and analytical skills in testing, developing and validating IT systems. Led teams of project managers for the development of the integration of IT services and system changes (SAP, SFDC, SharePoint). Developed and implemented Computerised Systems Validation procedures and systems. Promoted adoption and usage of new procedures through well-planned change management initiatives. Oversaw development of Human Resource documentation systems (LMI) as well as the Training and Resources management system.

ADVANCED BIONICS AG
Switzerland
4 Jahre 8 Monate
2007-11 - 2012-06

Enhanced systems stability

Team Leader - Production Systems Support & Training
Team Leader - Production Systems Support & Training
Enhanced systems stability by leveraging the strengths of a specialist team (3 direct local resources, and a virtual project team throughout the 23 branches worldwide) in managing systems availability and performance. Drove alignment of IT and business objectives. Developed and led the implementation of production application processes and procedures. Managed projects from beginning to end (time&material, and resources) related to implementation and validation of production devices including 3D printers, 3D scanners and associated modelling and management software. Led digital manufacturing and software/hardware fitting teams in the delivery of high-quality technical support for production systems. Coordinated installation of hearing aid production labs in branches worldwide, on time and within budget. Demonstrated knowledge of Medical Device Hardware and Software in compiling technical specifications and documents for Quality Management Systems.
PHONAK AG
Switzerland
2 Jahre 4 Monate
2005-07 - 2007-10

Held accountability and Project Management

International Technical Application Specialist & Trainer
International Technical Application Specialist & Trainer
Held accountability and Project Management for the international rollout of advanced manufacturing systems and services. Oversaw end-to-end application design, installation, and configuration of applications. Trained users on manufacturing equipment and services, both online and face-to-face. Applied troubleshooting and problem-solving skills in tracking technical failures and collaborated with engineering teams on equipment, software and system validation and improvement.
PHONAK AG
Switzerland

Aus- und Weiterbildung

2021

Brentwood University, Irvine, CA, (USA)

PhD DBA Doctor in Business Administration (Honours)


2017

University of Roehampton London, (UK)

MSc in Project Management (Distinction)


2012

CfPIE Center Professional Innovation and Education, Dublin (IE)

CSV Computerized Systems Validation (Certificate)


2011

MFQ ? Management for Quality Warrington (UK)

Internal QMS Auditor Certification on internal auditing of ISO 9001:2008 (Certificate)


2009

SONOVA Code of Ethics & Business Conduct - Ethical Decision Making (Coaching)


2003

MCI Code of Ethics & Business Conduct Long training program, Ethical Decision Making, Corporate Governance Training (Coaching)


1989

I.P.S.I.A.?G.MARCONI? Perugia, (IT)

Diploma, Electronic Engineering (58/60)


1987

I.P.S.I.A.?G.MARCONI? Perugia, (IT)

Certificate of Specialised Technician, (Certificate)

Kompetenzen

Top-Skills

IT Management IT Project Management Digital Transformation Expert Solution Architect Integration Architect Requirements Analysis & Management Technical Leadership Cross-functional Team Management Stakeholders Management Analytical & Problem-Solving Skills Result Orientation Quality Management Integration Risk Management Change Management Continuos Improvement Cloud GxP Compliance Microsoft365 & Office365 (Admin) GxP and GMAP5

Produkte / Standards / Erfahrungen / Methoden

Profile

  • Seasoned Project Manager and Digital Transformation expert with 15+ years of experience in Telecom, IT, and Life Science industries and a proven record of accomplishment of success in delivering excellence in complex international projects and programs. 
  • Deep expertise in IT/IS and QMS system integration, and Digital Transformation Management, with a talent for building consensus across large multi-cultural teams. Exceptional communication and interpersonal skills in working with Teams, customers and senior executives. Strong cooperative leader with a passion for continuous learning and personal and teams development. Vast industry and technical knowledge, a big-picture thinker with an appetite for success. 


IT Senior Project & Consultancy Manager

I thrive on challenging my understanding of digital technology through learning and practice. I am a humble technologist with a passion for digital innovation. For me, curiosity and creativity are the drivers for solutions and innovation. I strongly believe that we can thrive by being well-informed, pro-active, and passionate about what we do.


Skills

  • Project Management 
  • Consultancy practice 
  • Cooperative Leadership style 
  • Rolled-up sleeves approach 
  • Team Management 
  • Stakeholders Management 
  • Digital Transformation Expert 
  • Microsoft365 & Office365 
  • ISO13485/14971; IEC62304 
  • 21CFR part11 & part800 
  • GxP; GMAP5; MDR 
  • Quality Management Systems (QMS) 
  • Computerized Systems Validation (CSV) 
  • Quality Management (QA / QC) 
  • Risk Management 
  • Medical Devices 
  • Biotech 
  • Pharma 
  • IT & Telecommunication 
  • Cloud Computing 
  • Cloud GxP Compliance 
  • Problem Solving 
  • Agile 
  • Agile SCRUM 
  • Requirements Management 
  • Change Management 
  • Business Intelligence 
  • Compliance Intelligence


AREAS OF EXPERTISE

  • Project Management (Agile, Agile SCRUM)
  • Solution Architect
  • Integration Architect
  • Requirements Analysis & Management
  • Technical Leadership
  • Cross-functional Team Management
  • Stakeholders Management
  • Digital Transformation Expert
  • Analytical & Problem-Solving Skills
  • Result Orientation
  • Quality Management Integration
  • Risk Management
  • Change Management
  • Continuos Improvement
  • Cloud GxP Compliance
  • Business Intelligence
  • Microsoft365 & Office365 (Admin)
  • Medical Devices, Biotech, Pharma
  • ISO13485/14971; IEC62304
  • 21CFR part11 & part800
  • GxP and GMAP5
  • Quality Management Systems (QMS)
  • Computerized Systems Validation (CSV)


SOFT SKILLS

  • High degree of initiative and commitment
  • High level of communication and organisational skills
  • Structured way of working and high-quality delivery awareness
  • Good team player, competence in cross-functional cooperation
  • Hands-on sleeves-up mentality
  • Confident and self-assured appearance
  • High resilience, stress resistance and flexibility
  • Customer & Solution oriented

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