Interim Manager verfügbar

Interim Manager

verfügbar
Profilbild von Anonymes Profil, Interim Manager
  • 6410 Goldau Freelancer in
  • Abschluss: Quality Engineer B.A., Information Technology Engineer B.A.
  • Stunden-/Tagessatz:
  • Sprachkenntnisse: deutsch (Muttersprache) | englisch (Muttersprache)
  • Letztes Update: 16.10.2020
SCHLAGWORTE
PROFILBILD
Profilbild von Anonymes Profil, Interim Manager
DATEIANLAGEN
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Profil

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Projekt History

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SKILLS
Personal Information
Operations Manager, Advisor, Crisis Mediator, Transition and change management specialist, R&D Process & Design development, Regulatory compliance and transition projects, Remediation projects, DHF / Tech File review, Risk management, Data Integrity & Data Governance, SAP/ERP/MES QM-System Setup & Roll out, Cybersecurity and Vendor management.

Education / Experience
Quality- and Information Technology Engineer, Human Factors & Usability Engineering, Professional Project Manager and Leader, People’s development management and training, Conflict management, Crisis Management, Quality management. Working more than 25 years international.

Topics / Services / Technical skill set
  • Mediation & Crisis Management Leader
  • Multilevel Project Management Leader
  • Transition & Change Management 
  • Remediation Management
  • Regulatory Transition Management (e.g. MDD to MDR)
  • Audit/ Gap Analysis
  • Design Development 
  • Human Factors & Usability Engineering 
  • Design Verification & Validation
  • Method Validation / Method Transfer
  • Risk Management / HFE Risk Management 
  • Process, Qualification & Validation Management
  • CAPA Management, Training, CAPA Review Board (CRB)
  • Technical Documentation
  • Quality System: Development & Management
  • Regulatory Compliance & Applications (CE, FDA 510(k), CFDA ff.
  • Qualification & Validation: Process, Equipment, and Method’s
  • Computer System Validation (CSV) 
  • Data Integrity & Data Governance 
  • SAP / ERP QM-System Setup & Roll out
  • Cybersecurity (FDA / UL2900 Cybersecurity Standard for Medical Devices)
  • Compliance Audit 
  • cGxP and DI Training 
  • Supplier Audit & Management

PROJEKTHISTORIE
  • 05/2019 - 07/2020

    • Xenios AG
    • 250-500 Mitarbeiter
    • Pharma und Medizintechnik
  • Interim Head of Quality
  • Responsibility: 
    Daily QM/QA Management

    MDR implementation

    CFR 820 implementation

    Inspection & Audit preparation & management

    Employment of QM/QA Staff  

     

    Deliverables:

    Run daily QM/QA Management

    Implement EU MDR 2017/745 requirements

    Implement CFR 820 requirements
    Manage detailed work plans, groups and sequences as well as prioritize activities needed to successfully implement the requirements  

     

    • Develop resource plan
    • Employment 10+ QM/QA employees 
    • Define multiple work streams
    • Set up score cards and KPI 
    • Project controlling
    • Weekly reporting
    • Set up and moderate workshops
    • Manage burn down charts
    • Setup and report Management meetings and decision models 
    • Prepare and Lead NB TÜV-Audits
    • Prepare FDA Audit    

  • 01/2016 - 03/2019

    • Medela AG
    • 500-1000 Mitarbeiter
    • Pharma und Medizintechnik
  • Lead Project Manager Project Implementation QM/RA MDR-Program
  • Responsibility: 
    Implement and leading 9 work streams with approx. 50 members

     

    Deliverables:

    EU MDR 2017/745 requirements implementation in coordination with ISO 13485:216 and CFR 820 requirements.
    Create detailed work plans, groups and sequences as well as prioritize activities needed to successfully implement the requirements  

     

    • Develop resource plan 
    • Define multiple work streams
    • Set up score cards and KPI 
    • Project controlling
    • Weekly reporting /Score cards
    • Implement project risk management and escalation procedures
    • Set up and moderate workshops
    • Support work stream members
    • Manage the MDR requirement gap analysis and burn down chart
    • Setup and report Management meetings and decision models    

  • 08/2018 - 12/2018

    • Siemens Healthcare GmbH Germany, HQ
    • 1000-5000 Mitarbeiter
    • Pharma und Medizintechnik
  • Lead Project Manager Project Implementation NMPA former CFDA (China) QM/RA
  • Responsibility: 
    Leading multiple work streams

     

    Deliverables:

    Coordination, identification within Regulatory Affairs and regional units’ timely implementation of all aspects and change of the China agent and every legally and regulatory required artefacts (License, Label &IFU) for medical devices Class II / IIb in the portfolio of +820 Products

     

    • Regulatory Affairs / QM Management
    • Multiple Work Streams
    • Multi project management 
    • Project controlling
    • Weekly reporting /Score cards
    • Success reports to Management

    with other Business Lines, country organisations and the overall HQT/RA Management


  • 02/2018 - 12/2018

    • Ziehm Imaging GmbH Germany
    • 250-500 Mitarbeiter
    • Pharma und Medizintechnik
  • Remediation Project Leader Preparation to move the company and get ready for EU & International expected audits and certification at the new location
  • Deliverables
    Regulatory compliance & lean streamlining of “Production Control” processes

    Class II Imaging Products
     

    • GAP Analysis “Production controls requirements (ISO 13485:2016, 21CFR 820 QSR, MDR)
    • Update DHF, DHR and suppling doc’s
    • Risk Management / Risk Files 
      (ISO 14971 & MDR Preparation)
    • Update & write qualification & validation policies and SOP’s:

    Risk Management, Inventory, CSV, CS-Equipment, Data Integrity Calibration, Cleaning, Environment, Transport & Packaging 

    • Advice on SW APPs and Tools 
    • Advice on integrated IT production management (SAP / PLM / MES & interfaced App’s
    • Advice on Cybersecurity (UL29000ff)
    • Project & Team Matrix Management

  • 06/2017 - 12/2017

    • Fresenius-Kabi GMBH Bad Homburg
    • 1000-5000 Mitarbeiter
    • Pharma und Medizintechnik
  • FDA GxP & DI Gap Analysis & Internal Audit Leading DI & CSV Validation work stream Advise on general DI & Validation policy
  • Deliverables:

    FDA GxP & Data integrity Gap analysis 

     

    • Internal Audit / Gap analysis 
      ISO 14001,
      ISO 9001:2015 
      ISO 50001
      OHSAS 18001
      China GMP
      EU-GMP
      EU-GMP annex 11 
      FDA Data Integrity Audit &GAP
    • cGMP, 
    • GAMP5 Classifications
    • Establish Computer System Inventory
    • Execute risk analysis qualification & validation
    • Local plant MES/CS System, Risk Based DI & Audit Trail categorization
    • Define and write local leading VMP & CS-Validation, Qualification and Process Validation SOP’s 
    • Lead DI/RA Team Meetings
    • Lead general Validation & CSV policy and further steps
    • Deliver final CS Inventory

  • 11/2016 - 12/2017

    • Nobel Biocare AG Zürich
    • 500-1000 Mitarbeiter
    • Pharma und Medizintechnik
  • Design Development Compliance Lead & Human Factors Engineer
  • Deliverables:

    Remediation Project Leader Development 
    RA Compliance

    Sterile Barrier Systems & Non-Sterile Packaging Systems

    Sterile Class II Products
     

    • Design Development
    • Studies, DoE’s 
    • Risk Management / Risk Files 
      (ISO 14971 & MDR Preparation)
    • Design verification & validation 
    • Advise on QA & RA & 510(k) /CE Update and new registration
    • Supplier Qualification (ASL & Legal)
    •  Project & Supply Chain Budget 
    • Team Matrix Management
    • Design and execute Lab Tests 

    Stability / Integrity Tests

    Performance Tests

    Microbial Barrier Tests

    Interaction & Biocompatibility
    ISO 11607, EN-ISO, BIS, DIN, ASTM, IEC, TIR, MIL Standards

    • MDD to MDR Compliance
    • Handling & Human Factors / Rolls 

  • 07/2016 - 09/2016

    • Fresenius-Kabi GMBH, Graz
    • 1000-5000 Mitarbeiter
    • Pharma und Medizintechnik
  • GxP & DI Gap Analysis & Internal Audit Leading DI & CSV Validation work stream Adviser
  • Deliverables:

    FDA GxP & Data integrity Gap analysis 

     

    • Internal Audit / Gap analysis 
      ISO 14001,
      ISO 9001:2015 
      ISO 50001
      OHSAS 18001
      China GMP
      EU-GMP
      EU-GMP annex 11 
      FDA Data Integrity Audit &GAP
    • cGMP, 
    • GAMP5 Classifications
    • Establish Computer System Inventory
    • Execute risk analysis qualification & validation
    • Local plant MES/CS System, Risk Based DI & Audit Trail categorization
    • Define and write local leading VMP & CS-Validation, Qualification and Process Validation SOP’s 
    • Lead DI/RA Team Meetings
    • Lead general Validation & CSV policy and further steps
    • Deliver final CS Inventory

  • 03/2015 - 07/2016

    • Siemens Healthcare GmbH Digital Imaging, SYNGO Carve out of the Siemens AG
    • 1000-5000 Mitarbeiter
    • Pharma und Medizintechnik
  • Advisor and Interim Manager, Lead Project Manager Legal Manufacture Change Project Implementation / QM/RA
  • Responsibility: 
    Business Line: Digital Imaging, SYNGO
    Leading multiple work streams and a team of over 30 internal employees.

     

    Deliverables:

    Coordination, identification within Regulatory Affairs view and timely implementation of all aspects and change of the Legal Manufacturer on every legally and regulatory required artefact for decelerated medical devices Class II in the portfolio for +120 Countries with budget responsibility

     

    • Regulatory Affairs / QM Management
    • Multiple Work Streams
    • Multi project management 
    • Project controlling
    • Weekly reporting /Score cards
    • Success reports to Management
    • Resource management 
    • Budget management & controlling
    • Product re-registration in over 120 Countries
    • Coordination with other Business Lines, country organisations and the overall HC-QT Executive PMO

  • 11/2015 - 02/2016

    • TOMTEC Imaging System GmbH Munich
    • 50-250 Mitarbeiter
    • Internet und Informationstechnologie
  • Analyst & Advisor Product / Software design / RA / QM Human Factors process- improvement project
  • Deliverables: 
    Analyse and audit Product / Software design process from idea to finished product 

     

    Improve process landscape 

     

    • Analyze management process related to product design development / 3 management levels 
    • Analyze Product management processes
    • Analyse Software design &HFE processes and tools
    • Analyze Software risk management processes / full live cycle
    • Analyze Software QM management processes / full live cycle
    • Analyze Software RA processes and compliance 
    • ISO 9001 2015 Gap Analysis 
    • ISO 13485 Audit
    • ISO 14971 Audit
    • IEC 62304 2015 Audit / HFE
    • IEC 62366 2015 Audit/ HFE
    • 510(k) Submission doc / process review
    • Initialize & guide Improvement process

  • 03/2015 - 06/2015

    • Silony Medical AG
    • 10-50 Mitarbeiter
    • Pharma und Medizintechnik
  • Project Lead Computer System Validation SAP ECC CSV
  • Deliverables: 
    Implementation of Validation Policy into Present QM Policy

     

    Execute SAP ECC System Validation

    • MVP, VP, DQ, IQ, OQ, PQ, FR

     

    Validation Strategy 

    • IT Infrastructure
    • Validation Strategy
    • SOP Development
    • Validation Master Plan Development
    • GMP / FDA Compliance
    • HFE Compliance
    • CFR 820, CFR 820 part11
    • Din ISO 13485

    Policy and SOP’s

    • Document Controls
    • Change Controls
    • Validation Master Plan, IT-Validation
    •  Design Validation Template Documents for URS, FAT, SAT, VP, DQ, IQ, OQ, PQ, FR

  • 01/2014 - 03/2015

    • J&J DePuy Synthes
    • 1000-5000 Mitarbeiter
    • Pharma und Medizintechnik
  • Site Remediation Project Manager / PMO Multiple Site Coordinator
    • Multiple Work Streams
    • Multi project management 
    • Daily Huddle’s / Project controlling
    • Weekly reporting /Score cards
    • QPR / QSMRP preparation and presentation 
    • Glass Wall’s & Huddle Boards
    • Resource management over and for multiple sites
      Audit preparation
    • Budget management & controlling

     

    CAPA Subject Matter Expert / Interim Site CAPA Coordinator 


    CAPA Initiation, Bounding/ Containment, Correction, Investigation
    Root Cause Analysis, Corrective Actions, Preventive Actions, Rationales, 

    • CAPA Remediation
    • CAPA Review Board
    • Root cause investigations in to all business an compliance /QSIT areas
    • 5 Why’s, Ishikawa, D-FMEA, P-FMEA, HFE Risk management

  • 09/2013 - 06/2014

    • AbbVie (ex. Abbott)
    • 1000-5000 Mitarbeiter
    • Pharma und Medizintechnik
  • Project Lead, R&D & HFE Compliance Pre-Clinical Test Stage Method Validation / HFE Test Design NIS, NIS- AUTO
    • Packaging System
    • HFE &Transport Test Simulation
    • Test Method development for physical analytical Test Methods 
    • Method Validation for physical analytical Test Methods 
    • QM Master Validation Policy and SOP–design 
      Roll out of R&D Method Validation as a standard.
    • Policy roll out
    • Implementation and training
    • Presentation 
    • Combination Devices
    • NIS, NIS AUTO, PEN 
    • ISO 11608, MDD, cGMP, ICH, FDA RA- Guidance
    • Human Factors Engineering 

  • 05/2013 - 09/2013

    • Paul Hartmann AG /Corporate HQ Germany
    • 500-1000 Mitarbeiter
    • Pharma und Medizintechnik
  • Project Lead Multi Project Management, Design and QM
    • QM Master Validation Policy and SOP–design “Top down” roll out of the Corporate Quality Validation policy for all Group Members international as a standard.
       
    • Packaging System
    • Transport Test Simulation
    • Test Method development for physical analytical Test Methods 
    • Method Validation for physical analytical Test Methods 
    • Labelling

    • Process / Equipment Validation
    • -Software Validation CSV
    • Method Validation
    • Cleaning
    • Sterile Barrier Packaging
    • Sterilisation
    • Packaging System
    • Labelling
    • Transport 
    • Distribution
    • Policy roll out
    • Implementation and training
    • Presentation 

  • 04/2011 - 05/2013

    • Station 5 GMBH Berlin
    • < 10 Mitarbeiter
    • Architektur und Bauwesen
  • Interim Manager / Managing Director
    • Company structure and organisation
    • Vendor management
    • Service management
    • Management education
    • Software solution consulting
    • Human Factors Engineering Implementation and roll out 
    • QM /QA Policy Implementation and roll out 
    • QMH / Quality Management Handbook
       

  • 10/2010 - 03/2011

    • Evonik Services GMBH (ex Degussa AG)
    • 1000-5000 Mitarbeiter
    • Internet und Informationstechnologie
  • Management Coaching / Project management
  • GMP / FDA Compliance

    • IT Infrastructure
    • Network LAN Qualification Strategy
    • SAN / SAP System (PP, PM, MM, QM) Validation strategy
    • SOP Development
    • Qualification Master Plan Development
    • CFR 820, CFR 211, CFR 820 part11
    • Din ISO 13485
    • GMP / FDA Compliance
      • Integration present LAN / SAN infrastructure Systems
      • Integration present LAN / SAN infrastructure management Systems
      • Qualification Master Plan LAN /SAN
      • Change management LAN /SAN
      • SOP System LAN / SAN
      • SLA and standards LAN / SAN
      • Integration QM Policy
      • Integration QM System and Handbook
      • GxP Training Staff and management 

  • 01/2007 - 06/2010

    • Charlemagne Capital (IOM) LTD Portland Investment Company LTD Turtle Crawl Hill LTD
    • 50-250 Mitarbeiter
    • Architektur und Bauwesen
  • Interim & Investment Manager
    • Company structure and organisation
    • Investment Management
    • Vendor management
    • Purchase Management
    • Service management
    • Management education
    • Environment engineering
    • Human Factors engineering  
    • Software solution consulting
    • QM/ QA Policy implementation and roll out 

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