Manuel Kathofer - Quality Compliance Project Manager

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Bad Häring, Austria

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Experience

Jan 2024 - Present

2 years 11 months

Overall Project Manager for the Global Roll-Out of a Quality and Document Management System

International Medical Technology Company

Took over overall project management after the roll-out was discontinued the previous year
Determined the causes and planned the new approach
Organized and conducted qualification tests for the new software versions
Planned the project and coordinated all tasks and assignments at six locations worldwide as well as with the software supplier
Coordinated compliance topics with the Quality Heads at the locations
Organized and conducted Steering Committee meetings to report to management
Successful go-live in autumn 2024

Oct 2022 - Sep 2023

1 year

Project Manager for ISO27001 Implementation

Cloud Services Provider (AWS)

Initial analysis and assessment of current and target states
Determined the approach and introduced ISO27001 step by step
Conducted Stage 1 and Stage 2 audits
Certification without major or minor deviations

Oct 2021 - Dec 2023

2 years 3 months

External Project Manager for the Global Roll-Out of a Long-Term Storage Solution

Global Pharmaceutical Company

Organized and conducted all roll-out activities at four locations in Germany, Austria, the USA and China
Conducted project scoping phases to identify and classify all target systems
Planned the project, allocated tasks and roles, and organized and conducted the execution phases
Reported to global and local Steering Committees
Ensured compliance with the budget and timelines

Sep 2021 - Dec 2021

4 months

Project Manager for ISO9001 Implementation

Software Development GmbH

Built and introduced a quality management system according to ISO9001:2015
Analyzed and optimized existing processes with a focus on support, development, agile project management and Scrum
Determined the measures required to achieve ISO9001 compliance
Defined the SOPs and created the QM manual
Trained employees and the QMB and prepared for external audits
Supported the audit and certification

Feb 2020 - Jun 2020

5 months

Project Manager for ISO9001 Implementation

Software Development GmbH

Built and introduced a quality management system according to ISO9001:2015
Analyzed and optimized existing processes with a focus on support, development and project management
Determined the measures required to achieve ISO9001 compliance
Defined the SOPs and created the QM manual
Trained employees and the QMB and prepared for external audits
Supported the audit and certification

Oct 2019 - Dec 2022

3 years 3 months

External Project Manager Data Integrity for Long-Term Storage and Archiving of Critical Raw Data

Development of procedures and methods for the long-term archiving of critical laboratory and production data
Analysis of the various source data formats of applications and systems to be replaced
Clustering of application types and development of archiving strategies according to ALCOA+ principles
Evaluation and selection of possible target systems for long-term archiving
Implementation using allotropic file formats
Creation of global SOPs for replacing various source systems and applying archiving solutions
Coordination of project teams in the USA, Germany, Austria and China

Sep 2018 - Nov 2021

3 years 3 months

External QA Manager and Validation Expert

Uniklinikum St. Pölten

GMP validation expert and external QA consultant for the introduction of new blood bank software
Introduction and implementation of CSV methodologies according to GAMP5
GMP training and instruction of laboratory and IT employees
Organization of all validation processes: infrastructure, qualification of laboratory equipment, validation of software applications, quality assurance and quality control
Application to all sub-processes: appointment organization, donation management, laboratory analyses, reporting, production and storage

Mar 2017 - Jul 2019

2 years 5 months

Senior Device Development Consultant

Sandoz GmbH

Preparation, completion and expansion of regulatory documentation (DHF, DMR) for medical and combination products in the EU and US markets in accordance with 21 CFR 820
Internal Change Control Manager for development and commercialization products
Interface between departments such as QA, QC, Packaging and Development
Management of several projects, including various administration forms of Etanercept and Adalimumab (Needle-Safety-Device, Autoinjector)

Feb 2017 - Dec 2017

11 months

Project Manager Data Integrity in QC Processes

Böhringer Ingelheim

Analysis and assessment of all GMP-validated laboratory applications with regard to ALCOA+ requirements
Creation of Process Data Maps and an implementation plan for Data Integrity Bio Pharma
Alignment of Process Data Maps for various QC processes
Training participants to create Process Data Maps based on requirement documents
Review and assessment of manufacturing and LIMS processes regarding GMP compliance according to ALCOA+
Conducting FMEA risk assessments
Definition and assessment of measures to meet compliance requirements

Jan 2017 - May 2017

5 months

Project Manager for the Introduction of ISO9001

Transport and Logistics Company

Establishment and introduction of a quality management system according to ISO9001:2015
Analysis, adjustment and optimization of existing processes
Definition of SOPs and creation of the quality management manual
Training of employees and the QMB
Preparation for external audits and audit support for certification

Apr 2016 - Dec 2016

9 months

Wels, Austria

Project Manager for the Implementation of an IHE Communication Platform

IT Healthcare Company

Project planning, effort estimation and team coordination
Sprint planning and status meetings
Implementation of an IHE-compatible platform for connecting healthcare providers with Orchestra®
Definition of milestones for the development of the various IHE handlers
Team coordination

Apr 2015 - Oct 2016

1 year 7 months

Project Manager for the Introduction of a DWH

Upper Austria Regional Association of the Red Cross

Overall project manager for the introduction of a DWH solution based on MS SQL Reporting Services
Data transfers from SAP IS-H, FI/CO, HR and other applications
Replacement of legacy systems, including the transfer of historical data
Development of data marts and data structures
Mapping of the authorization system based on Active Directory

Jun 2014 - Nov 2014

6 months

Austria

Project Manager for the Introduction of ISO9001

Optical Components Development and Manufacturing Company

Development and introduction of a quality management system according to ISO9001 and ISO14001
Definition of SOPs and creation of the quality management manual
Training of employees and the QMB
Preparation for and support during external certification audits
Upgrade and TÜV certification to ISO9001:2015 in summer 2016

Aug 2013 - Dec 2013

5 months

Austria

Project Manager for the Introduction of ISO9001

Engineering and Plant Development Company

Development and introduction of a quality management system according to ISO9001
Definition of SOPs and creation of the quality management manual
Training of employees and the QMB
Preparation for and support during external certification audits
Planning the extension to ISO9100 for aerospace suppliers

Jun 2011 - Dec 2016

5 years 7 months

Linz, Austria

Project Manager for the Linz Blood Center

Upper Austria Regional Association of the Red Cross

Overall project manager for the introduction and GMP validation of the New Medical Software (NMS) for all sub-processes
Design and introduction of innovations such as reagent management, biobank, sample management and data archiving
End-to-end batch tracking according to cGMP regulations
Took over project management after the project was stopped, including restructuring and personnel reorganization
Development and validation of a LIMS as well as redesign of the IT architecture
Integration and GMP qualification of laboratory automation systems (Architekt, Prism, Sysmex, Cobas) and external customers (HL7)
Development of the GMP-compliant quality management documentation structure and performance of internal and external audits
Support for the restructuring of the IT department and coordination of external service providers
Milestone planning, project controlling and reporting to the project supervisory board

Jun 2011 - Mar 2015

3 years 10 months

Project Manager for the Introduction of Central Billing

Rotes Kreuz Landesverband Oberösterreich

Overall project manager for the introduction of a system for the administration and billing of rescue and patient transport services
Preparation of the solution concept and tender documents
Conducting the tender process and evaluating bids
Introduction of SAP IS-H with interfaces to third-party applications (emergency physician documentation, DaMe, ELGA)
Specification, development and commissioning of Win8 apps for mobile applications in emergency services

Mar 2011 - May 2011

3 months

Tübingen, Germany

Blood Bank Processes Consultant

Universitätsklinikum Tübingen

Preparation of a hospital-wide target concept for tracking blood batches in accordance with the Blood Transfusion Act (TFG)
Analysis of current processes and documentation status on wards
Process analysis in the blood bank and pharmacy, as well as modelling of delivery and administration processes
Definition of feedback processes for patient-related billing
Preparation of a requirements catalogue, user requirements, target process and system requirements
Support during vendor selection

Jun 2008 - Mar 2011

2 years 10 months

Munich, Germany

Quality & Risk Manager; Vice President Global Project Management

EXTEDO

Further development and maintenance of the ISO9001:2008- and GAMP5-compliant quality management system
Introduction of new and optimization of existing SOPs, as well as conducting internal and external audits
Risk management and software risk assessments
Validation planning and execution in software development processes (Category 3–5)
Standardization of IQ, OQ and PQ, as well as preparation of templates for validation documentation
Roll-out of the quality management system to locations in Philadelphia (USA) and Birmingham (UK)
Implementation of eCTD-based submission management systems for authorities and companies
Development of consulting services for CROs and pharmacovigilance solutions
Responsible for customer support and expanding regulatory consulting services
Project management for DMS infrastructure, VPN access and terminal server architectures
Contributed to the business continuity concept

Jan 2008 - Dec 2010

3 years

Innsbruck, Austria

Managing Director and Quality Manager

AFreeze GmbH

Transition of the start-up from the preclinical testing stage to serial production
Introduction and certification according to EN13485 – Medical Devices
Definition and standardization of all company processes
Preparation for and execution of audits with the certification body
Expansion of the quality management system and process organization throughout the company

Industry experience

See where this freelancer has spent most of their professional time.

Experienced in Healthcare, Pharmaceutical, Manufacturing, Information Technology, Transportation, and Aerospace and Defense.

Healthcare

Pharmaceutical

Manufacturing

Information Technology

Transportation

Aerospace and Defense

Business area experience

See which departments and functions this freelancer has contributed to most.

Experienced in Project Management, Quality Assurance, Information Technology, Accounting, Production, and Product Development.

Project Management

Quality Assurance

Information Technology

Accounting

Production

Product Development

Skills

Professional Focus

Corporate Management, Interim Management, Project Management
Controlled & Efficient Development Processes In Software And Hardware
Quality Management, Compliance & Risk Management: Iso9001, Iso13485, Iso27001, 21cfr820, Dsgvo, Gmp, Gamp5 Csv (Computer System Validation), Data Integrity, Iec61508 –Safety Critical Systems
Certified Dsgvo Consultant
Iso9001:2015 Auditor

Professional Competencies

Corporate Management / It Project Management: Planning And Implementation Of Complex It Projects, Leadership Of Teams In Diverse Areas: Infrastructures, Implementation Of Sw Applications, Software Application & Product Development, Commissioning Of Control Systems
Quality-Critical Projects: Efficient Project Management While Complying With Critical Requirements – E.G. Traffic Telematics, Blood Bank Systems, Elga/Ehealth, Manufacture Of Pharmaceutical Products, Etc.
Business-Critical Projects: Database Replications And Multiple Sites, Distributed Dms (Document Management Systems), Data Consolidation, Distributed Systems And Organizations, Data Security And Security Solutions
Monitoring And Compliance With Budgets, Milestones And Effort Plans
Project And System Documentation According To Selected Qm Standards
Improvement And Optimization Of Software And Hardware Development Processes: Reduction Of Warranty Cases, Rework And Hotline Workload
Restoration Of Process Controllability, Documentation Of Legacy Systems
Restoration Of Profitability, Billing Of Services
Introduction Of Quality Management And Compliance With Various Qm Standards
Obtaining Certificates, Attestations And Operating Permits (Customers, Authorities)
Simultaneous Compliance With Multiple Qm Standards, Safety And Risk Management In Complex It Projects
Introduction, Adaptation And Optimization Of Qm Systems
Change Processes In Organizations, Procedures And Responsibilities
Audit Preparation, Conducting Internal And External Audits, Certification Audits, Representing Organizations Before Authorities, Customers Or Certification Bodies
Project Management, Controlled & Efficient Development Processes
Planning, Automation And Optimization Of Production Processes And Controls (Mainly Process Engineering)
Interfaces To Erp Systems And Production Planning Systems For Material Usage Calculations And Optimization Tasks
Introduction And Improvement Of Qm Systems According To Iso9001:2015, Cmmi, Dsgvo, En13485 Medical Devices, Design Controls 21 Cfr 820.30, Gamp5, Gmp, Csv (Computer System Validation), Cfr21 Part11, Data Integrity, Pic/S-Guide
Specialized Knowledge Of Fail-Safe And Safety-Critical Systems Iec 61508
Audit Preparation, Organization And Execution Of Internal And External Audits By Authorities Or Business-Critical Customers
Training, Teaching Fundamentals, Application And Best Practices
Creating Awareness, Reorganizing Responsibilities And Supporting Change Processes (Change Management)
Corporate Management, Business And Budget Planning, Recruiting And Team Building, Development Of New Business Areas
Planning And Execution Of Mergers And Acquisitions
Investor Search And Corporate Financing
Interim Management As Managing Director, Vice President, Department Head, Quality And Risk Manager
Project Manager For Particularly Business-Critical Projects
Building, Reorganizing And Securing Success In Sales And Development Departments
Preparation, Execution And Safeguarding Of Acquisitions/Mergers, Both In Terms Of Personnel And Business

Technical Competencies

Applied Quality Management: Iso9001, En13485, Iso14971, Iso27001, 21cfr820, Iec61508, Gamp5, Gmp, Eu-Gmp Guide Annex 11, Cfr21 Part11-Compliance, Data Integrity, Alcoa+, Cmm/Cmmi, Dsgvo
Development: Microsoft Windows All Platforms; Vb, C/C++, C#, Java, Progress, Abap4; Sql; All Procedural And Object-Oriented Development Languages (Fortran, Pascal, Modula-2, Chill, Etc.), Html, Java
Development Tools: Microsoft Visual Studio, Subversion, Jira, Confluence (Atlassian)
Databases: Microsoft Sql Server, Oracle (Database Replications)
Applications: Ms Office, Ms Project, Ms Visio, Process4biz, Sap Is-H, Trackwise, Document Management Systems (Dms)
Standards: Bpmn, Hl7, Ihe, Elga, Efa

Languages

German

Native

English

Advanced

Education

Oct 1986 - Jun 1991

Vienna University of Technology

Diplomingenieur, Technical Computer Science and Applied Data Processing · Technical Computer Science and Applied Data Processing · Vienna, Austria

Certifications & licenses

Ima – Advanced Coaching: Führung und Motivation von Managern

Ima

Ima – Train The Trainer

Ima i.e. "Institute for Management Altran"

Cobit5 Foundation

En13485 – Medizintechnik

Gewerbeberechtigung für Automatische Datenverarbeitung & Unternehmensberatung sowie Arbeitskräfteüberlassung

Irca Iso9001:2015 Auditor

Validierungen computerisierter Systeme nach GMP/GAMP5

Zertifizierter DSGVO Berater

eCTD-Submissions und Reviewing

Statistics

Experience

Total positions 19

Experience in Healthcare 14.5 y

Avg length 1 y 10 m

Longest experience 5 y 6 m

Global experience

Countries worked in 2 (Austria, Germany)

Primary country Austria

Expertise

Recent roles Overall Project Manager for the Global Roll-Out of a Quality and Document Management System, Project Manager for ISO27001 Implementation, External Project Manager for the Global Roll-Out of a Long-Term Storage Solution

Main industries Healthcare, Pharmaceutical, Manufacturing

Main business areas Project Management, Quality Assurance, Information Technology

Qualifications

Highest degree Master

Certifications earned 9

Member since

June 2025

Last update

October 2026

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Frequently asked questions

Have questions? Find more information here.

Manuel is based in Bad Häring, Austria and can operate in on-site, hybrid, and remote work models.

Manuel speaks the following languages: German (Native), English (Advanced).

Manuel has at least 19 years of experience. During this time, Manuel has worked in at least 16 different roles and for 16 different companies. The average length of individual experience is 1 year. Note that Manuel may not have shared all experience and actually has more experience.

Based on recent experience, Manuel would be well-suited for roles such as: Overall Project Manager for the Global Roll-Out of a Quality and Document Management System, Project Manager for ISO27001 Implementation, External Project Manager for the Global Roll-Out of a Long-Term Storage Solution.

Manuel's most recent position is Overall Project Manager for the Global Roll-Out of a Quality and Document Management System at International Medical Technology Company.

In recent years, Manuel has worked for International Medical Technology Company, Cloud Services Provider (AWS), Global Pharmaceutical Company, Software Development GmbH, and Uniklinikum St. Pölten.

Manuel is most experienced in industries like Healthcare, Pharmaceutical, and Manufacturing. Manuel also has some experience in Information Technology, Transportation, and Aerospace and Defense.

Manuel is most experienced in business areas like Quality Assurance, Project Management, and Information Technology. Manuel also has some experience in Accounting, Production, and Product Development.

Manuel has recently worked in industries like Healthcare, Pharmaceutical, and Manufacturing.

Manuel has recently worked in business areas like Project Management, Quality Assurance, and Information Technology.

Manuel holds a Master in Technical Computer Science and Applied Data Processing from Vienna University of Technology.

Manuel has 9 certificates. Among them, these include: Ima – Advanced Coaching: Führung und Motivation von Managern, Ima – Train The Trainer, and Cobit5 Foundation.

The availability of Manuel needs to be confirmed.

Daily rate distribution

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Daily rate avg. 825 €

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Median rate 820 €

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Calculated based on our freelancers’ daily rates as of 5 Nov 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.

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