a Randstad company

Medical Devices, Life Sciences, Digital Transformation, IoT, Industry 4.0, Program/Project Mgmt, QA/RA, GRC

Profil
Top-Skills
Regulated Industries: Medical Devices & Life Sciences Digital Transformation Internet of Things (IoT) Program & Project Management Quality Management Regulatory Affairs Governance, Risk, Compliance Design Thinking Data Privacy Cyber Security Robotics Industry 4.0
Verfügbar ab
16.08.2022
Noch verfügbar - Schnell sein lohnt sich: Der Experte kann bereits für Projekte vorgesehen sein.
Verfügbar zu
100%
davon vor Ort
0%
Einsatzorte

PLZ-Gebiete
Länder

Please note that I am available for FULLY REMOTE assignments ONLY - assignments that require any degree of personal presence on-site or travel. even to a small degree or sporadically, are NOT POSSIBLE.

Remote-Arbeit
möglich
Art des Profiles
Freiberufler / Selbstständiger
Der Experte ist als Einzelperson freiberuflich oder selbstständig tätig.

1 Jahr 8 Monate

2021-01

heute

GRC (Governance/Risk/Compliance), QA/RA (Quality Assurance / Regulatory Affairs), CS (Cyber Security) ? Submission of documents for registration of Medical Devices & Regulatory Requirements / Best Practice

QA/RA, GRC, Cyber Security Consultant (FDA/GxP regulated industries) ISO 13485 ISO 14971 ISO 60601 ...
Rolle
QA/RA, GRC, Cyber Security Consultant (FDA/GxP regulated industries)
Projektinhalte

Synopsis:

Creating, processing, and reviewing product documentation for submission to regulatory bodies (FDA, EMA) for registration of medical devices under different submission paths (De Novo, EUA / Emergency Use Authorization, U-EAU / Umbrella Emergency Use Authorization. 510(k) / Pre-Market Notification, PMA / Pre-Market Approval).

Tasks/Responsibilities:

  • Research, verify, and approve device information in regulatory databases, such as e.g. active device registration & listings, GUDID, product classification, device class, product code, device definition, GMDN code, GMDN terms, GMDN term preferred name, GMDN title & number, device ID, device characteristics, etc.

  • Provide guidance to clients for registration of FURLS accounts.

  • Engage in submission of regulatory documents for PPE (Personal Protective Equipment), including surgical masks and respirators, N95 masks (US), KN95 masks (CN), FFP2/FFP3 masks, EU type IIR masks.

  • Engage in submission of regulatory documents for the De Novo registration of a Cold Ablation Robot-guided Laser Osteotome device.

  • Cyber Security assessment (device classification, assessment of potential threats, vulnerabilities, mitigation measures etc.) for the Cold Ablation Robot-guided Laser Osteotome as a Tier 2 device.

  • Serve as PRRC (Person Responsible for Regulatory Compliance) as defined by EU MDR 2017/745.

  • Advise a client (a major Swiss life science company) in regard to

    ? regulatory requirements (GxP, Cyber Security, etc.) when moving existing software applications used in a regulated environment, that are critical to product quality, into the cloud;
    ? regulatory requirements (GxP, Cyber Security, etc.) when deploying COTS applications in the cloud;
    ? regulatory requirements (GxP, Cyber Security, etc.) when developing new

    applications in-house to be deployed in the cloud;

  • Consulting in regard to best practices for introducing and deploying a scaling agile methodology (in this case: SAFe) in DevSecOps and throughout the whole organization.

  • Consulting in regard to creating and implementing a Cloud Governance Framework that would blend in with, and complement, existent regulatory and quality corporate policies.

Produkte
MS Office LibreOffice various web-based online tools
Kenntnisse
ISO 13485 ISO 14971 ISO 60601 ISO 61010 ISO 62304 ISO 62366 ISO 27xxx IEC 80001 21 CFR GxP EN 14683 FDA De Novo Guidance FDA Cyber Security Guidance NIST CS Framework NIOSH Guidance Agile Scrum Kanban SAFe DevSecOps Best Practice Requirements Engineering & Management Risk Management FMEA Cloud Governance Framework
Einsatzort
Fully remote
2 Jahre 4 Monate

2018-11

2021-02

Consulting in Digital Transformation / IoT / Industry 4.0 / Factory Automation / Cyber Security

Management Consultant Digital Transformation Digital Business IoT ...
Rolle
Management Consultant
Projektinhalte

Helping clients to ideate, define, challenge and implement strategies, business models, target operating models, technologies and implementation roadmaps in order to master the challenges of Digital Transformation, the Internet of Things, Industry 4.0 topics, and relevant underlying or related technologies, such as Robotics, Factory Automation, Machine Learning, Cloud, etc.

Facilitating and leveraging methodologies and strategies such as Design Thinking, Innova- tion & Knowledge Management, Human-Centered Design, Customer Journey etc, to create awareness and build up momentum for implementing a truly Digital Culture throughout the entire organization, as an indispensable precondition of successful Digital Transformation.

Tasks/Responsibilities:

  • Technological, social, economic aspects and effects of the Digital Transformation in general, and on a client?s specific business.

  • Big Data - how to generate, accumulate, manage, and mine them.

  • Cloudification of legacy on-premise systems and applications.

  • Possible application scenarios and advantages of blockchain technology.

  • The capabilities of Intelligent Robotics, Autonomous Systems, Machine Learning / AI, and how to put them to use in Factory Automation of Industry 4.0 manufacturing plants.

Kenntnisse
Digital Transformation Digital Business IoT Internet of Things Industrial Internet of Things Industry 4.0 Factory Automation Big Data Analytics Cyber Security Regulatory Affairs Compliance GDPR
Einsatzort
Switzerland / EU / Turkey
2 Jahre 6 Monate

2016-05

2018-10

Lead of Corporate Digital Transformation Program

Global Program Manager Digital Transformation Digital Business IoT ...
Rolle
Global Program Manager
Projektinhalte
Global lead of the "Connectivity Solutions" program, the company’s effort to bundle all ideas, resources, assets, R&D activities, and client solutions relating to the company’s digital trans- formation under a joint oversight and governance body responsible for coordinated planning, management, and project execution, in order to maximize efficiency and synergies, and to minimize overhead and duplicate work. The program serves to align all DT efforts with the digital strategy of the corporate group. Being an expression of the company’s belief that the future of healthcare is digital and connected, it emphasizes the commitment to be at the forefront of the digital revolution and a leader in the digital transformation in healthcare.
 
Tasks/Responsibilities:
  • Head of the global program "Connectivity Solutions", the company's joint R&D effort in the Digital Transformation / IoT / Industry 4.0 domain.

  • Managing stakeholder and representing the program within the Belimed group and to external partners and clients.

  • Regulatory oversight (GRC) of the program.

  • Portfolio & product management, ideation, innovation and continuous improvement with

    regard to the product ideas, prototypes and MVPs managed within the program.

  • Act as technical SPOC for R&D, internal stakeholders and external partners.

  • Development and definition of the R&D roadmap, product increments, MVPs, release milestones, coordination of the test management with external implementation partners.

  • Requirements elicitation / analysis / engineering with regard to functional and non- functional product, market, and regulatory requirements.

  • Subject matter expert for development of Belimed’s digital roadmap with focus on Digital Transformation, Internet of Things, Industry 4.0, Machine to Machine Communication, Big Data, Cloud Technology, and Advanced Analytics / Artificial Intelligence.

  • Project manager and subject matter expert for Belimed’s laboratory & equipment management system (ICS) and the development of its designated successor.

  • Vendor management and management of the Design Transfer for an IoT MDDS (data aggregation & store-and-forward proxy) solution.
  • Pre-sales and client consulting for all topics regarding the Connectivity Solutions program and its portfolio.
Kenntnisse
Digital Transformation Digital Business IoT Internet of Things Industrial Internet of Things Industry 4.0 Factory Automation Big Data Analytics Medical Devices Cyber Security Regulatory Affairs Compliance GDPR
Einsatzort
Zug
8 Jahre 4 Monate

2008-01

2016-04

Executive & Management Consulting? PgM, QA/RA, OE, GRC

Executive & Management Consultant ? PgM, QA/RA, OE, GRC Quality Management Regulatory Affairs Management Verification ...
Rolle
Executive & Management Consultant ? PgM, QA/RA, OE, GRC
Projektinhalte

CynetiX Technology Consulting GmbH is a partner-managed Swiss consulting, research and development, and technology management firm, specializing in regulated and strictly quality driven industries, such as Medical Devices, Life Sciences, Aerospace, Defense, and Energy.

Providing consulting in the areas of Quality Assurance, Regulatory Affairs, and Governance/ Risk/Compliance to domestic and international clients in regulated industries, primarily in Medical Devices, Life Sciences, and Healthcare.

Special Operations (R&D, lab systems, special purpose & custom systems).

Tasks/Responsibilities:

Providing consulting in the areas of Regulatory Affairs, Quality Assurance, and Governance/Risk/Compliance to domestic and international clients in regulated industries, primarily in Medical Devices, Life Sciences, and Healthcare.
Consult and support clients in analysis, definition, implementation, improvement, supervision and enforcement of quality and regulatory (e.g. QSR/GxP, HIPAA/HITECH, EHR) compliance, operational safety policies, data security policies, definition, review, and improvement of the process landscape, and alignment of processes to business.


Sample Consulting Assignment:


Subject Matter: Quality Assurance / Regulatory Compliance Role: Quality & RA Manager
Industry: Medical Devices
Period: 2014/08 to 2015-01

References: 2 – 3, upon request

Responsibilities:
Supported several R&D projects (in-house und OEM) as RA and QM subject matter expert: lab analytics instruments such as readers, washers, multi-mode readers with various hardware modules/ operation modes/ assay configurations for optical detection (Luminescence, Absorbance, Fluorescence, AlphaScreen/AlphaLISA, etc.)
Provided advisory consulting as RA subject matter expert in preparation of an FDA inspection

Tasks:

  • Represented the QM/RA department in project steering committees and R&D teams
  • Ensured product compliance with regard to 21 CFR Part 820, MDD 93/42/EEC, ISO 13485, 14971, 62304, 62366, 60601, EU Machinery Directive, and environmental regulations (ROHS/REACH)
  • Creation, maintenance, review, release of control documents such as Design Specifications, Test Plans, Test Reports, Master Test Plan, Engineering Design Output, Validation Master Plan, PQ/DQ/IQ/OQ plans, etc.
  • Execution and acceptance of PQs, DQs, IQs, OQs, PLV
    Planning, coordination, and execution of various remediation activities, such as:
  • Re-documentation: review, correction, re-release of obsolete/incorrect project/product documentation (DHF, DHR, DMR)
  • Review, correction, re-release of risk assessments: correcting form, wording, and risk assessments in PHAs, FMEAs in the areas of design, production/process, and service
  • Review, correction, re-release, and management of NCRs, CAPAs, HHAs
  • Management of the DHR of various devices
  • Supported continuous improvement of the process landscape: assessments, gap analysis, redesign, validation.
Kenntnisse
Quality Management Regulatory Affairs Management Verification Validation Qualification Quality Assurance Quality Control CAPA NCR HHA FMEA Validation Master Plan VMP IQ OQ PQ DQ SOP Test Plan Test Report PLV Design Input Design Output R&D Research & Development 21 CFR 820 MDD 93/42/EEC ISO 13485 ISO 14971 ISO 62304 ISO 62366 ISO 60601 ISO 9000 ISO 9001 RoHS REACH EU Machinery Directive FDA PHA Preliminary Hazard Analysis DHF Design History File Device Master Record DMR Device History Record DHR Good Manufacturing Practice GMP Good Automated Manufacturing Practice GAMP 510(k) IVD 98/79/EC EudraLex 2006/42/EC eCTD HIPAA HITECH EHR Electronic Health Record Health Information Privacy Device Ergonomics cDWH 21 CFR 21 CFR Part 11 21 CFR Part 820 21 CFR Part 808 21 CFR Part 812 HAZOP FTA HACCP Electronic Records Electronic Signatures Notified Body Health Canada China FDA PMDA ANVISA COFEPRIS TGA SDLC FMECA QSR Quality System Regulation Clean in Place CIP Steam in Place SIP Wash in Place WIP
Kunde
CynetiX Technology Consulting GmbH
Einsatzort
Switzerland
8 Jahre

2000-01

2007-12

Technology & Management Consulting

Technology & Management Consultant Project Management Data Center Migration ...
Rolle
Technology & Management Consultant
Projektinhalte

Sample Assignment (information on other assignments available upon request):


CoriMed, Inc. – USA

2002 – 2003

Project Manager & Technology Consultant (freelance)

Medical IT / Healthcare

Consulting, planning and pre-test implementation in a large-scale data center consolidation project. Consolidation of a Windows 2000 TS / Citrix MetaFrame environment of about 80 servers of a mixed standalone / failover / cluster configuration running Windows 2000 Advanced Server + Terminal Services, Citrix MetaFrame 1.8, NFuse, SQL Server, Exchange, into four IBM x/440 machines running VMware ESX Server. In parallel, a smooth migration of the SQL Server / Exchange environment towards an Open Source solution (Linux / IMAP / PostgreSQL), and from MS Office to an OpenOffice environment has been prepared. Integration of various UNIX-based medical applications and medical workstations (Solaris, AIX, HP-UX), and designing a connector architecture to an SAP (IS-H/Med) back-end system.

Technical project management including planning, organizing, and supervising the complete 510k & GxP compliant documentation process; working closely with clinical clients on implementation, usability, and compliance issues.

Consulting and support in the systems & operating environment analysis, and in writing development and systems documentation, such as: Proof of Concept Whitepaper, Requirements Specification, Design Specification, System Engineering Specification, Integrations Testing Whitepaper, Testing Manual, Migrations Testing Whitepaper, Migration Manual, System Failure & Disaster Recovery Whitepaper, Operating Manual.

Designed upgrade & replacement roadmap, cost analysis & control (TCO calculation), and budgeting Successfully completed the migration project on time, on scope, on budget

Produkte
IBM x/Series Open Source Citrix Linux IMAP IBM AIX Solaris PostgreSQL Windows Microsoft Exchange SAP IS-H/Med Microsoft SQL Server HP-UX 510(k) GxP
Kenntnisse
Project Management Data Center Migration Consolidation Computer Systems Validation CSV Documentation Good Documentation Practice Compliance
Kunde
International clients in various industries (Automotive, Aerospace/Defense, Energy, Financial Services, Information Technology, Medical Technology, Oil/Gas, Telecommunication)
Einsatzort
International Locations
6 Jahre 5 Monate

1993-08

1999-12

Development of a Medical Imaging (PACS) Online Archive

Project Manager / Member of Project Steering Group DICOM HL-7 HIS ...
Rolle
Project Manager / Member of Project Steering Group
Projektinhalte

Development of a Medical Imaging (PACS) Online Archive. Planning, design and implement- ation of a hardware & software reference platform for a leading-edge, cost efficient digital online archiving system to store medical images (PACS), based on off-the-shelf Intel x86 Hardware and Windows NT, with standard network connection to large-scale medical imaging systems (Siemens Coroscope/ Bicor/ Polytron etc.) and real-time review devices (ACOM.M/.B/.PC), clinical data sources (HIS/RIS), clinical workstations, and clinical administrative back-end systems (IS-H/Med) via DICOM/HL7-driven communication.

Tasks/Responsibilities:

  • Member of the international PSG (Project Steering Group), serving the roles of project manager, quality manager, and regulatory affairs manager for system design & architecture throughout the entire SDLC according to GMP regulations.
  • Coordinated development and engineering tasks between German, U.S., and Swedish locations.
  • Designed the system architecture from scratch for hardware, software, and infrastructure.
  • Designed the data model, and supervised DBMS setup, configuration, and performance
  • Tuning of the object-oriented database.
  • Worked closely with the engineering team during implementation of the prototype,
  • Integration, performance, and quality tests. Handled change request management.
  • Authoring of 510(k) & GMP compliant documentation, including Requirements Specification, System Analysis Specification, System Design Specification, System Engineering Specification, and System Maintenance Specification.
  • Accompanied analysis and definition of use cases, and authoring of System Administration Manual and Clinical User Manual. Prepared and supervised prototype implementation and authoring of documentation as QM for FDA auditing.
  • Coordinated communications between distributed developer teams in Germany, the U.S., Sweden, and India. Organized and drove information flow from DICOM task force and developer team of the PACS class library (pre-Syngo product) to the ACOM.Net developer teams.
  • Worked closely with clinical users during design & implementation phase, drove and supervised installation and operation of prototypes at hospitals, taking part in clinical trial tests (St. Mary's Hospital Chicago, German Heart Disease Center Munich, Heart Disease Research Center Bad Oeynhausen).
  • Close involvement with working out the product development roadmap, upgrade & replacement roadmap. Managed QM/QA on cost analysis & budgeting, throughout all phases of the project.
  • Accompanied early adopter clinical clients during product introduction as aftersales technical manager, providing the clients a direct link to 3rd level technical support and engineering.
Produkte
BICOR Polytron Coroscope MagicView ACOM.M ACOM.B ACOM.Net VAX
Kenntnisse
DICOM HL-7 HIS RIS IS-H/Med Medical Imaging PACS Inter-Modality Communication CR CT DX MR NM PT PX ST US XA Clinical Workflow eCTD Clinical Data Archiving cDWH Clinical ERP
Kunde
Siemens Medical Solutions
Einsatzort
USA (with temporary assignments to Germany and Sweden)
EXECUTIVE SUMMARY

I am an executive-level manager, specializing in Regulatory Affairs, IT Governance & Strategy, Enterprise IT Management, and Transition Management, bringing in-depth expertise in Life Sciences, Aerospace & Defense, and ICT industry, and solid experience in Automotive, Energy, and Telecommunication.

Featuring a strong record of achievement and proven professional competency in various job roles, I am combining strong technological knowledge and product experience with excellent methodical, organizational, and people skills, in areas such as program & project management, compliance, auditing, governance, quality & risk management, enterprise technology stack & architecture, next generation/?green? data center, organizational development, process management & improvement, and leadership & team building.

I have broad knowledge in methodologies, technologies, and frameworks, along with international, multi-cultural work experience and globally successful consulting practice.

Balancing rationality, intuitiveness, and ?the human touch?, I am highly adaptive to changing business requirements, able to maintain rigorous quality standards under pressure and heavy workload, and effective at building partnerships, community and human relations.


PROFESSIONAL EXPERTISE

Regulatory Affairs, Quality, GRC
  • Regulatory expertise for: USA (FDA), Canada (Health Canada), European Union (Notified Bodies), China (CFDA), Japan (PMDA), Brazil (ANVISA), Mexico (COFEPRIS), Australia (TGA)
  • 21 CFR Part 820 (QSR, cGMP, PHA, FMEA, CAPA, HHA, PDCA cycle)
  • 21 CFR Part 11 (Electronic Records and Electronic Signatures)
  • FDA Q9 QRM (PHA, FMEA, FMECA, FTA, HACCP, HAZOP)
  • 21 CFR Part 808 (Device Exemptions)
  • 21 CFR Part 812 (Clinical Investigations)
  • GAMP5, Computer Systems Validation (CSV), SDLC, SOPs
  • Validation Process Management (Project Plan, VMP, IQ, OQ, PQ)
  • Validation Master Plan (VMP) creation, maintenance, management
  • System Reliability & Risk Analysis (Design/Functional/Process FMEA & FMECA)
  • 510(k) Clearance (Pre-market Notification)
  • ISO 9001 (QS continuous improvement process)
  • ISO 13485 (EU/ECC QSR)
  • ISO 14971 (Risk Management for Medical Devices)
  • ISO 62304 (Medical Device Software SLC)
  • ISO 62366 (Application of usability engineering to medical devices)
  • MDD 93/42/EEC (EU Medical Device Directive)
  • IVD 98/79/EC (EU In Vitro Diagnostic Medical Device Directive)
  • AIMDD 90/385/EEC (EU Active Implantable Medical Device Directive)
  • ICH Q7 (GMP), ICH Q9 (QRM)
  • EU Machinery Directive (2006/42/EC) (application to, and compliance of, machinery which is part of, used by, or together with medical devices, e.g. automated/robotic lab systems)
  • Environmental Compliance of (medical) devices: RoHS (2002/95/EC), REACH (EC No 1907/2006), WEEE (2002/96/EC)
  • HIS, RIS, Medical Imaging / PACS (systems, architecture, implementation)
  • Clinical IT Infrastructure (architecture, design, implementation, operation, continuity)
  • Clinical IT Security, Threat & Vulnerability Assessment/ Analysis/ Remediation
  • Clinical ERP (IS/H, i.s.h.med)
  • Healthcare IT Standards (DICOM, HL-7, MEDICOM, IHE, ACC, NEMA, RSNA, HIMSS, etc.)
  • Inter-/cross-modality communication & integration (CR, CT, DX, MR, NM, PT, PX, ST, US, XA, etc.)
  • Clinical Workflows
  • Clinical Trials (CTMS, EHR4CR, ICE), Document Management (eCTD), Data Archiving (cDWH)
  • Device ergonomics & UX/usability of clinical applications
  • EHR & Health Information Privacy (HIPAA, HITECH Act, Directive 2011/24/EU)
  • Business Continuity, Disaster Recovery Planning, SOX-404 Compliance in the Healthcare industry
 
Program & Project Management
  • Management of the entire Program/Project Life Cycle, from preliminary evaluation studies through proposals, initiation, implementation/delivery, to post-implementation review and close/handover, including governance and process alignment, quality and risk management, business liaison, and stakeholder management, in accordance and compliance with the chosen methodology.
  • In-depth experience in a number of prominent and popular project management methodologies, such as PMBoK, DSDM, Scrum, PRINCE2, Classic (V/Waterfall), and Integrium Clinical Excellence (ICE) methodology for clinical trials.
  • OGC Best Practice Models (working knowledge and hands-on experience with PRINCE-2, MSP, P3O, ITIL).
  • Practical experience with industry-specific, localized, and proprietary project management methodologies like Hermes (Swiss Federal Administration) and PM2go (Swiss Federal Railways).
  • Program/Project Planning & Life Cycle Management
  • Quality Management
  • Risk Management
  • Service Management (ITIL)
  • Budget Management (GAAP-compliant CAPEX/REVEX/OPEX budgeting)
  • Procurement, Staff & Resource Management, Sourcing & Contract Administration
  • Stakeholder, Partner & CR Management
  • Process Management/Improvement/Transformation
  • Project Presentation, Representation, Reporting
  • Provide leadership, motivation and strategic direction to a multifaceted team.
  • Effectively work as lead, as part of a team, and on own initiative.
  • Build and maintain close relationship with suppliers and contractors.
  • Liaise with external consultants and contractors to ensure that project objectives are met.
  • Achieve results in high pressure environments and to keep people motivated.
  • Represent the program/project as SPOC to Executive Management.
 
Governance, Strategy, Transition Management
  • Define, implement, and manage GRC-based Corporate ICT Strategy for Regulated Industries
  • Define, implement, and manage GRC-based Corporate ICT Sourcing Strategy for Regulated Industries
  • Define, implement, and manage ICT Roadmaps
  • Define, implement, and manage ICT Infrastructure, Platform, Middleware, and Application portfolios
  • Implement and manage Governance Standards (TOGAF, CoBIT, CMMI, Six Sigma, ITIL)
  • Corporate ICT Orchestration, Alignment, (Re)Organization, and Transformation
  • Organizational Transition Management: define, implement, and manage lightweight, agile organizational structures & patterns, business processes, seamlessly aligned ICT processes, and a responsive, demand-driven, service-centered ICT support organization
  • ICT Strategy Alignment & Transformation for New/Emerging Technologies (Cloudification, Big Data, Mobility, BYOD)
  • Improve efficiency of business processes, leverage synergies, and create and increase business value by making intelligent use of ICT
  • Devise strategies to integrate legacy systems and modernize aging ICT architectures
  • Apply, implement, and manage architectural models at different levels
  • Application of EA models and frameworks to specific industries (e.g. Medical Devices, Life Sciences, Aeropace/Defense, Transportation/Railway, Automotive)
  • Business Continuity, Disaster Recovery Planning, SOX-404 Compliance
 
Enterprise IT
  • Enterprise Unix platforms (IBM p/Series, AIX, HACMP cluster, z/Series Unix facility, SUN Sparc Platform, Solaris)
  • Enterprise open source platforms (Debian Linux, Ubuntu Linux, Redhat Linux/RHEL, FreeBSD)
  • Enterprise-grade virtualization (VMware vSphere)
  • Enterprise middleware stack (IBM WebSphere, DataPower)
  • Enterprise storage (Shark, EMC)
  • EIA, SOA, ESB, multi-tier architectures
  • Web application technology stacks (JEE, Rails)
  • Cloudification Strategy (governance-driven approach to private, public, hybrid clouds)
  • Cloudification Architecture & Implementation (IBM SmartCloud, Amazon EC2, Salesforce Force.com)
  • Big Data & Data Mining (IBM InfoSphere, IBM Cognos)
  • Business Intelligence
  • Document Management
  • Workflow Management
 
Data Center
  • ANSI/TIA-942 standard
  • Uptime Institute standard
  • Modeling criteria
  • Design programming
  • Design recommendations
  • Conceptual design
  • Technology infrastructure design
  • Availability planning
  • Energy efficiency / ?green? design
  • Infrastructure management (DCIM)
  • Non-stop operations / 24 x 365 / continuity

Soft Skills
  • Excellent inter-cultural communication, negotiation, moderation, mediation, and rhetorical skills
  • Excellent language proficiency in English and German, both oral and written
  • Very flexible and adaptive to changing conditions. Highly focused and able to pursue and meet set goals even under excessive workload and high pressure
  • Strong strategic, analytical, and structured thinking, excellent organizational and coordination skills
  • Customer-minded, 100% strictly solution-centered practitioner

 


LANDMARK FIGURES

The following numbers should give an idea of the scale of my projects up to present :
 

  • Largest budget : ~ DM 65 Million (~EUR 33.5 Million)
  • Largest team size : ~ 85 persons
  • Longest assignment : ~ 5 years
  • Largest IT environment : ~ 20,000 systems
  • Highest consulting position : reporting directly to CEO & Board of Directors



WORK PERMIT & CITIZENSHIP INFORMATION

 
  • Nationality: Swiss
  • Work permit: Switzerland, EU


CAREER HISTORY





Academic Education

  • University of California
    San Diego, California 1999 ? 2000
    Project Management, Management Information Systems
    extra-curricular coursework
  • Loyola University
    Chicago, Illinois 1996 ? 1999
    Psychology, Computer Science
    extra-curricular coursework
  • Friedrich-Alexander-Universität
    Erlangen, Germany 1993 ? 1996
    Philosophy (major), Political Science (1st minor), Computer Science (2nd minor)
    B.A. in Philosophy / Political Science

 

Professional Training

  • 2014: IT Security Awareness Training for CIOs (2 days)
  • 2014: PMI PmBoK 5th Ed. update (3 days)
  • 2013: IBM InfoSphere Master Data Management (2 days)
  • 2013: IT Security Awareness Training for CIOs (2 days)
  • 2012: Benchmarking Project Success (1 day)
  • 2012: IT Security Awareness Training for CIOs (2 days)
  • 2011: GxP Validation Management: MasterControl for Site Operators (3 days)
  • 2011: GxP Validation Management: MasterControl for Project Users (2 days)
  • 2011: IT Security Awareness Training for CIOs (2 days)
  • 2011: CHIME Healthcare CIO Boot Camp (3.5 days)
  • 2010: IT Security Awareness Training for CIOs (2 days)
  • 2010: Scrum Product Owner (2 days)
  • 2009: Continual Improvement Assessment (CIA) (1 day)
  • 2008: DSDM Atern for PMPs (4.5 days)
  • 2008: Failure Mode and Effects Analysis (FMEA) (2 days)

 

Vocational Training

  • German Armed Forces ? Air Force
    Fort Bliss, USA 1989 ? 1991
    Training as Officer of the Reserve for Technical Service in Information Systems Technology
    for electronic combat support systems
    Training as Information Systems Support Engineer for electronic combat support systems

SPECIALIZING IN

  • Medical Devices
  • Life Sciences
  • FDA-Regulated Industries

BRINGING IN-DEPTH EXPERTISE IN

  • Program & Project Management
  • Quality Assurance
  • Regulatory Affairs
  • Digital Transformation / Digital Business

  • Ideation / Innovation / Design Thinking
  • R&D / New Product Development
  • IoT (Internet of Things) / Industry 4.0 / Factory Automation
  • Cyber Security for Regulated Industries & IoT

COMPREHENSIVE EXPERIENCE IN

  • Enterprise IT Strategy & Governance
  • Organizational Excellence
  • Enterprise IT Operations Management

  • Studies, concept whitepapers, analysis reports, management reports


All services are available either on an FTE or fixed price basis. Please contact me for details and available options.

Deutsch native
Englisch native
Russisch basic
Spanisch basic

Top Skills
Regulated Industries: Medical Devices & Life Sciences Digital Transformation Internet of Things (IoT) Program & Project Management Quality Management Regulatory Affairs Governance, Risk, Compliance Design Thinking Data Privacy Cyber Security Robotics Industry 4.0
Aufgabenbereiche
Cyber Security Digital Business Digital Transformation Factory Automation Industry 4.0 Regulatory Affairs
Produkte / Standards / Erfahrungen / Methoden
Big Data Analytics Compliance GDPR Industrial Internet of Things Internet of Things IoT Medical Devices
Regulatory Affairs, Governance, Risk, Compliance, Quality Management
  • 21 CFR Part 820 (FDA QSR, cGMP, CAPA, PDCA)
  • 21 CFR Part 11 (QS implementation of controls)
  • FDA Q9 QRM (FMEA, FMECA, FTA, HACCP, HAZOP, PHA)
  • 21 CFR Part 808 (device exemptions)
  • 21 CFR Part 812 (clinical investigations)
  • GAMP5, Computer Systems Validation (CSV)
  • System Reliability & Failure Mode Analysis (Functional / Design / Process FMEA & FMECA)
  • 510(k) Clearance
  • ISO 62304 (medical device software SLC)
  • ISO 13485 (EU/ECC QSR)
  • ISO 14971 (Risk Management for medical devices)
  • ISO 9001 (QS continuous improvement process)
  • ICH Q7 (GMP), ICH Q9 (QRM)
  • HIS, RIS, Medical Imaging / PACS (systems, architecture, implementation)
  • Clinical IT Infrastructure (architecture, design, implementation, operation, continuity)
  • Clinical IT Security, Threat & Vulnerability Assessment/ Analysis/ Remediation
  • Clinical ERP (IS/H, i.s.h.med)
  • Healthcare IT Standards (DICOM, HL-7, MEDICOM, IHE, ACC, NEMA, RSNA, HIMSS, etc.)
  • Inter-/cross-modality communication & integration (CR, CT, DX, MR, NM, PT, PX, ST, US, XA, etc.)
  • Clinical Workflows
  • Clinical Trials (CTMS, EHR4CR, ICE), Document Management (eCTD), Data Archiving (cDWH)
  • Device ergonomics & UX/usability of clinical applications
  • EHR & Health Information Privacy (HIPAA, HITECH Act, Directive 2011/24/EU)
  • Business Continuity, Disaster Recovery Planning, SOX-404 Compliance in the Healthcare industry
  • Document & Workflow Management

Program & Project Management
  • Methodologies (DSDM, Scrum,PMI/PMBOK, PRINCE-2, Classic (Waterfall, V))
  • Techniques (mind maps, meta plans, network plans, GANTT diagrams etc.)
  • Tools (Spider Project, OpenPlan, MS Project, CA SuperProject)
 
Betriebssysteme
Linux (Debian-based flavors) macOS / Mac OS X Various BSD Unix flavors Various legacy OS (OpenVMS, MVS) Various Unix flavors (AIX, Solaris)
Programmiersprachen
None

Average skill with various scripting languages such as Bash, Perl, PHP, AppleScript. A little Python and Swift.


!!! PLEASE NOTE: I AM NOT A SOFTWARE DEVELOPER !!!

Datenkommunikation
ESB SOA
Hardware

Experience with enterprise systems of various vendors, e.g. IBM, Sun, Fujitsu, Dell, EMC, etc.

Experience with various industrial controller families, e.g. Siemens S7, Rockwell, Allen-Bradley, GE.

Experience with IoT controller plattforms (primarily Raspberry Pi).

  • Long-term work experience abroad (USA, UK, Sweden, Austria, Netherlands, etc.) and in large-scale international projects
  • Comprehensive, in-depth experience in Program & Project Management in large-scale projects (budget/investment > $50 million)
  • Experience in line management, enterprise IT operations (data center, cloud solutions, infrastructure, workplace) management, supply chain management, auditing, coaching

Medical Devices

Life Sciences / Biotech

Pharma

Healthcare


Aerospace & Defense

Automotive

IT Industry

Manufacturing

Oil / Gas / Power / Utilities

Railway / Public Transport

Telecommunications


EXCLUDED (I do NOT wish to work in these industries):

Finance (Banking / Insurance)

Governmental / Public Administration (except for Public Healthcare)

Ihr Kontakt zu Gulp

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