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Last update: 10.06.2021

Interim Manager

Company: iqc GmbH
Graduation: Quality Engineer B.A., Information Technology Engineer B.A.
Hourly-/Daily rates: show
Verhandelbar
Languages: German (Native or Bilingual) | English (Native or Bilingual)

Skills

Personal Information
25+ years successful professional Manager and Leader. Advisor, Mediator. Transition and change management expert. C-Level Interim Manager.

Experience
Operations Manager. Conflict Mediator. Transition and change management. Regulatory compliance and transition projects in multi-site and mixed matrix environment. Remediation projects. Data Risk Management. Data Integrity & Data Governance. New IOT Service & Update SW delivery technology. IT Infrastructure. QM & Compliance System Setup & Roll out, Cybersecurity and Vendor management. Build new relationships. 

Skill set
Project management methods. People’s potential development. Intercultural & interpersonal mediation and conflict/crisis management. Integration and direction in M&A mixed managements. Line up-, set targets, control, interact, and correct. Budget & CAPEX management. Think out of the box. Hands on and lean management culture.

Topics / Services 
  • Remediation Management
  • M&A Due Diligence
  • Multilevel Project /Multi Site Management Leader
  • People’s development management
  • Intercultural communication and conflict management
  • Find the right people for the required role 
  • cGxP, QMS, QSR and DI Training
  • External / Internal Audit, Supplier Audit Management 
  • Regulatory Transition Management
  • Human Factors & Usability Engineering 
  • Technical Documentation
  • Regulatory Compliance & Applications 21 CFR4, 21CFR 820, 21CFR 210/211, cGMP, EU-GMP, CFDA/NMPA ff.
  • Computer System Validation (CSV) 
  • SaMD Development EC 62304, ISO 14971, ISO 13485, ISO 62366 (Usability) and similar
  • Data Integrity & Data Governance 
  • SAP / ERP, MES, LIMS, QM-System Setup & Roll out
  • Cybersecurity (FDA / UL2900 Cybersecurity Standard)
  • Compliance Audit 
Education 
Lifelong learning of professional management
1993, Information Technology Engineer B.A., DEC, Digital Equipment Academy
1986, Quality Engineer, Mechanical Engineering B.A., Berufsakademie Kaiserslautern

Project history

01/2021 - 05/2021
Auditor / Regulatory Compliance Review / QA
IVD Life Science IVD Company, USA (Confidential NDA)

FDA / ICH / ISO / IVDR (EU) regulated

Function: Auditor / Regulatory Compliance Review / QA 

Responsibility:
Audit / Gap Analysis, Clinical Performance Study Program compliance
CFR, ICH, IVDR & ISO-Standard compliance 

Inspection & Audit preparation 
Deliverables:
QMS, SOP, WI, Forms & Contract review & gap analysis
Implement CFR, ICH, IVDR & ISO requirements

Prioritize activities
Set up and moderate workshops
Manage burn down charts
Prepare for Authority Inspections and Notified Body Audit


07/2020 - 12/2020
Cleaning / Disinfection Validation & Study Lead
Zimmer Medizin System GmbH, Germany (250-500 employees)
Pharmaceuticals and medical technology

Medical Devices Company 

MDR / ISO regulated

Function: Cleaning / Disinfection Validation & Study Lead 

Responsibility:

MDR compliance implementation Cleaning / Disinfection Validation
Deliverables:

Gap Analysis QMS System 

Gap Analysis, SOPs Cleaning & Disinfection Process & Program

Implement EU MDR 2017/745 and ISO Standard requirements
- Set up and moderate workshops

- Identify current applicable standards and guidance

- Develop & write Design of Experiment (DoE) Study Plans 

- Guide execution of DOE Studies

- Develop & write Validation Plans & SOPs

- Plan & guide external validation with external Laboratory 

 


05/2019 - 07/2020
Interim Head of Quality
Xenios AG (250-500 employees)
Pharmaceuticals and medical technology

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
Lead Project Manager Project Implementation QM/RA MDR-Program
Medela AG (500-1000 employees)
Pharmaceuticals and medical technology

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
Lead Project Manager Project Implementation NMPA former CFDA (China) QM/RA
Siemens Healthcare GmbH Germany, HQ (1000-5000 employees)
Pharmaceuticals and medical technology

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
Remediation Project Leader Preparation to move the company and get ready for EU & International expected audits and certification at the new location
Ziehm Imaging GmbH Germany (250-500 employees)
Pharmaceuticals and medical technology

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
FDA GxP & DI Gap Analysis & Internal Audit Leading DI & CSV Validation work stream Advise on general DI & Validation policy
Fresenius-Kabi GMBH Bad Homburg (1000-5000 employees)
Pharmaceuticals and medical technology

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
Design Development Compliance Lead & Human Factors Engineer
Nobel Biocare AG Zürich (500-1000 employees)
Pharmaceuticals and medical technology

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
GxP & DI Gap Analysis & Internal Audit Leading DI & CSV Validation work stream Adviser
Fresenius-Kabi GMBH, Graz (1000-5000 employees)
Pharmaceuticals and medical technology

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
Advisor and Interim Manager, Lead Project Manager Legal Manufacture Change Project Implementation / QM/RA
Siemens Healthcare GmbH Digital Imaging, SYNGO Carve out of the Siemens AG (1000-5000 employees)
Pharmaceuticals and medical technology

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
Analyst & Advisor Product / Software design / RA / QM Human Factors process- improvement project
TOMTEC Imaging System GmbH Munich (50-250 employees)
Internet and Information Technology

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
Project Lead Computer System Validation SAP ECC CSV
Silony Medical AG (10-50 employees)
Pharmaceuticals and medical technology

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
Site Remediation Project Manager / PMO Multiple Site Coordinator
J&J DePuy Synthes (1000-5000 employees)
Pharmaceuticals and medical technology
  • 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
Project Lead, R&D & HFE Compliance Pre-Clinical Test Stage Method Validation / HFE Test Design NIS, NIS- AUTO
AbbVie (ex. Abbott) (1000-5000 employees)
Pharmaceuticals and medical technology
  • 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
Project Lead Multi Project Management, Design and QM
Paul Hartmann AG /Corporate HQ Germany (500-1000 employees)
Pharmaceuticals and medical technology
  • 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
Interim Manager / Managing Director
Station 5 GMBH Berlin (< 10 employees)
Architecture and civil engineering
  • 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
Management Coaching / Project management
Evonik Services GMBH (ex Degussa AG) (1000-5000 employees)
Internet and Information Technology

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
Interim & Investment Manager
Charlemagne Capital (IOM) LTD Portland Investment Company LTD Turtle Crawl Hill LTD (50-250 employees)
Architecture and civil engineering
  • 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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