Manuel Kathofer - Overall project manager for the global roll-out of a quality and document management system

Q: Where is Manuel based?

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

Q: What languages does Manuel speak?

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

Q: How many years of experience does Manuel have?

Manuel has at least 18 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.

Q: What is Manuel's latest experience?

Manuel's most recent position is Overall project manager for the global roll-out of a quality and document management system at International medical device company .

Q: What companies has Manuel worked for in recent years?

In recent years, Manuel has worked for International medical device company , Cloud services provider (AWS) , Global pharmaceutical company , Software development company , and University Hospital St. Pölten .

Q: Which industries is Manuel most experienced in?

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

Q: Which business areas is Manuel most experienced in?

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 .

Q: Which industries has Manuel worked in recently?

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

Q: Which business areas has Manuel worked in recently?

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

Recommended expert

Bad Häring, Austria

Check rate

Experience

Jan 2024 - Present

2 years 6 months

Overall project manager for the global roll-out of a quality and document management system

International medical device company

Took over overall project leadership after the roll-out was stopped the previous year
Identified causes and planned a new approach
Organized and conducted qualification tests of new software versions
Planned and coordinated all tasks and assignments at six sites worldwide and with the software provider
Aligned compliance topics with the quality heads at the sites
Organized and held steering committee meetings to report to management
Successful go-live in fall 2024

Oct 2022 - Sep 2023

1 year

Project manager for ISO 27001 implementation

Cloud services provider (AWS)

Initial analysis and assessment of current and target states
Defined approach and phased implementation of ISO 27001
Conducted stage 1 and stage 2 audits
Achieved certification with no major or minor findings

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 executed all roll-out activities at four sites in Germany, Austria, the USA, and China
Conducted project scoping phases to identify and classify all target systems
Project planning, task and role assignment, and organization and execution of execution phases
Reported to global and local steering committees
Ensured adherence to budget and timelines

Sep 2021 - Dec 2021

4 months

Project manager for ISO 9001 implementation

Software development company

Established and implemented a quality management system according to ISO 9001:2015
Analyzed and optimized existing processes focusing on support, development, agile project management, and Scrum
Identified necessary measures to achieve ISO 9001 compliance
Defined SOPs and created the QM manual
Trained employees and the quality management representative and prepared for external audits
Supported audits and achieved certification

Feb 2020 - Jun 2020

5 months

Project manager for ISO 9001 implementation

Software development company

Established and implemented a quality management system according to ISO 9001:2015
Analyzed and optimized existing processes focusing on support, development, agile project management, and Scrum
Identified necessary measures to achieve ISO 9001 compliance
Defined SOPs and created the QM manual
Trained employees and the quality management representative and prepared for external audits
Supported audits and achieved certification

Oct 2019 - Dec 2022

3 years 3 months

External data integrity project manager for long-term storage and archiving of critical raw data

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

Sep 2018 - Nov 2021

3 years 3 months

External quality management representative and validation expert

University Hospital St. Pölten

GMP validation expert and external quality management consultant for the implementation of new blood bank software
Introduction and implementation of CSV methodologies according to GAMP5
GMP training and instruction of lab and IT staff
Organization of all validation processes: infrastructure, qualification of lab equipment, software application validation, quality assurance and control
Application to all subprocesses: appointment scheduling, donation management, lab analyses, reporting, production and storage

Mar 2017 - Jul 2019

2 years 5 months

Senior Device Development Consultant

Sandoz GmbH

Creation, supplementation and expansion of regulatory documentation (DHF, DMR) for medical and combination products in the EU and US markets according to 21 CFR 820
Internal change control manager for development and commercialization products
Interface function between departments such as QA, QC, packaging and development
Management of multiple projects including different administration forms of etanercept and adalimumab (needle safety device, autoinjector)

Feb 2017 - Dec 2017

11 months

Project manager for data integrity in QC processes

Böhringer Ingelheim

Analysis and evaluation of all GMP-validated lab applications regarding ALCOA+ requirements
Creation of process data maps and implementation plan for data integrity in biopharma
Alignment of process data maps for various QC processes
Training participants on creating process data maps based on requirement documents
Review and evaluation of manufacturing and LIMS processes for GMP compliance according to ALCOA+
Conducting FMEA risk assessments
Defining and evaluating measures to meet compliance requirements

Jan 2017 - May 2017

5 months

Project manager for ISO 9001 implementation

Transport and logistics company

Establishment and implementation of a quality management system according to ISO 9001:2015
Analysis, adjustment and optimization of existing processes
Definition of SOPs and creation of the quality management manual
Training of employees and the quality management representative
Preparation for external audits and audit support for certification

Apr 2016 - Dec 2016

9 months

Wels, Austria

Project Manager for Implementation of IHE Communication Platform

IT Healthcare Company

Project planning, effort estimation, and team coordination
Sprint planning and status meetings
Implementation of an IHE-compatible platform to connect healthcare providers with Orchestra®
Defining milestones for developing the various IHE handlers
Coordinating the teams

Apr 2015 - Oct 2016

1 year 7 months

Project Manager for Data Warehouse Implementation

Austrian Red Cross, Upper Austria Branch

Overall project manager for implementing a data warehouse solution based on MS SQL Reporting Services
Data transfers from SAP IS-H, FI/CO, HR, and other applications
Replacing legacy systems including legacy data migrations
Building data marts and data structures
Mapping the permission system based on Active Directory

Jun 2014 - Nov 2014

6 months

Austria

Project Manager for ISO 9001 Implementation

Optical Components Development and Manufacturing Company

Developing and implementing a quality management system according to ISO 9001 and ISO 14001
Defining SOPs and creating the QM manual
Training employees and the QM representative
Preparing for and supporting external audits for certification
Upgrading and TÜV certification to ISO 9001:2015 in summer 2016

Aug 2013 - Dec 2013

5 months

Austria

Project Manager for ISO 9001 Implementation

Engineering and Plant Development Company

Developing and implementing a quality management system according to ISO 9001
Defining SOPs and creating the QM manual
Training employees and the QM representative
Preparing for and supporting external audits for certification
Planning the extension to ISO 9100 for aerospace suppliers

Jun 2011 - Dec 2016

5 years 7 months

Linz, Austria

Project Manager, Blood Center Linz

Austrian Red Cross, Upper Austria Branch

Overall project manager for implementation and GMP validation of the new medical software (NMS) across all sub-processes
Designing and introducing innovations such as reagent management, biobank, sample management, and data archiving
End-to-end batch tracking according to cGMP regulations
Taking over project management after project halt, restructuring, and personnel reorganization
Setting up and validating a LIMS and redesigning the IT architecture
Integrating and GMP-qualifying laboratory instruments (Architect, Prism, Sysmex, Cobas) and external clients (HL7)
Developing a GMP-compliant QM documentation structure and conducting internal and external audits
Supporting the restructuring of the IT department and coordinating 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 Central Billing Implementation

Red Cross Regional Association Upper Austria

Overall project manager for implementing a system to administer and bill emergency and patient transports
Developing the solution design and tender documents
Running the tender process and evaluating bids
Implementing SAP IS-H with interfaces to third-party applications (emergency doctor documentation, DaMe, ELGA)
Specifying, developing, and commissioning Win8 apps for mobile use in emergency services

Mar 2011 - May 2011

3 months

Tübingen, Germany

Blood Bank Process Consultant

University Hospital Tübingen

Creating a hospital-wide target concept for blood batch tracking in accordance with the Blood Transfusion Act (TFG)
Analyzing current workflows and documentation levels in wards
Analyzing processes in the blood bank and pharmacy and modeling the delivery and administration processes
Defining feedback processes for patient-related billing
Creating a requirements catalog, user requirements, target processes, and system requirements
Supporting vendor selection

Jun 2008 - Mar 2011

2 years 10 months

Munich, Germany

Quality & Risk Manager; Vice President Global Project Management

EXTEDO

Further developing and maintaining the ISO9001:2008 and GAMP5-compliant QMS
Introducing new and optimizing 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)
Standardizing IQ, OQ, and PQ as well as creating templates for validation documentation
Rolling out the QMS to sites in Philadelphia (USA) and Birmingham (UK)
Implementing eCTD-based submission management systems for regulatory agencies and companies
Developing consulting services for CROs and pharmacovigilance solutions
Responsible for customer support and expanding regulatory consulting offerings
Planning DMS infrastructure, VPN access, and terminal server architectures
Contributing to the high-availability concept

Jan 2008 - Dec 2010

3 years

Innsbruck, Austria

Managing Director and Quality Manager

AFreeze GmbH

Transitioning the start-up from preclinical trial stage to series production
Implementing and certifying according to EN ISO 13485 for medical devices
Defining and standardizing all company processes
Preparing for and conducting audits with the certification body
Expanding the QMS and process organization across the entire 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 Areas

Corporate Leadership, Interim Management, Project Management
Controlled & Efficient Development Processes In Software And Hardware
Quality Management, Compliance & Risk Management: Iso 9001, Iso 13485, Iso 27001, 21 Cfr 820, Gdpr, Gmp, Gamp5 Csv (Computer System Validation), Data Integrity, Iec 61508 – Safety-Critical Systems
Certified Gdpr Consultant
Iso 9001:2015 Auditor

Professional Competencies

Corporate Leadership / It Project Management: Scoping, Planning, And Execution Of Complex It Projects, Leading Teams In Diverse Tasks: Infrastructure, Sw Application Rollout, Software Application & Product Development, Commissioning Of Control Systems
Quality-Critical Projects: Efficient Project Management While Meeting Critical Compliance Requirements – E.G., Traffic Telematics, Blood Bank Systems, E-Health, Pharmaceutical Products Manufacturing Etc.
Mission-Critical Projects: Database Replications And Multiple Locations, Distributed Dms (Document Management Systems), Data Consolidations, Distributed Systems And Organizations, Data Security And Security Solutions
Monitoring And Adherence To Budgets, Milestones, And Effort Plans
Project And System Documentation Following Selected Qm Standards
Improvement And Optimization Of Software And Hardware Development Processes: Reducing Warranty Cases, Rework, And Hotline Load
Restoring Process Controllability, Documenting Legacy Systems
Restoring Profitability, Billing Services
Implementing Quality Management And Compliance With Various Qm Standards
Achieving Certifications, Approvals, Operating Licenses (Clients, 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, Workflows, And Responsibilities
Audit Preparation, Conducting Internal And External Audits, Certification Audits, Representing Organizations Before Authorities, Clients, Or Certification Bodies
Project Management, Controlled & Efficient Development Processes
Designing, Automating, Optimizing Production Processes And Controls (Mainly Process Engineering)
Interfaces To Erp Systems, Production Planning Systems For Material Usage Calculations And Optimization Tasks
Implementing And Improving Qm Systems According To Iso 9001:2015, Cmmi, Gdpr, En 13485 Medical Technology, Design Controls 21 Cfr 820.30, Gamp5, Gmp, Csv (Computer System Validation), Cfr 21 Part 11, Data Integrity, Pic/S Guide
Special Knowledge In Fault-Tolerant And Safety-Critical Systems Iec 61508
Audit Preparation, Organization And Execution Of Internal And External Audits By Authorities Or Key Clients
Training, Teaching Fundamentals, Application, And Best Practices
Raising Awareness, Reorganizing Responsibilities, Supporting Change Processes (Change Management)
Corporate Leadership, Business And Budget Planning, Recruiting And Developing Employees, Creating New Business Areas
Planning And Executing Mergers And Acquisitions
Sourcing Investors And Corporate Financing
Interim Management As Ceo, Vice President, Department Head, Quality And Risk Manager
Project Lead In Highly Mission-Critical Projects
Building, Reorganizing, And Securing Success In Sales And Development Departments
Preparing, Executing, And Ensuring M&A Both In Personnel And Financially

Technical Competencies

Applied Quality Management: Iso 9001, En 13485, Iso 14971, Iso 27001, 21 Cfr 820, Iec 61508, Gamp5, Gmp, Eu-Gmp Guide Annex 11, Cfr 21 Part 11 Compliance, Data Integrity, Alcoa+, Cmm/Cmmi, Gdpr
Development: Microsoft Windows All Platforms; Vb, C/C++, C#, Java, Progress, Abap4; Sql; All Procedural And Object-Oriented 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

Diploma in Technical Informatics and Applied Data Engineering · Technical Informatics and Applied Data Engineering · Vienna, Austria

Certifications & licenses

Ima – Advanced Coaching: Leadership and Motivation of Managers

Ima

Ima – Train the Trainer

Ima (Institute for Management Altran)

Cobit5 Foundation

EN 13485 – Medical technology

Business license for automatic data processing & business consulting and temporary staffing

IRCA ISO 9001:2015 Auditor

Validation of computerized systems under GMP/GAMP5

Certified GDPR consultant

eCTD submissions and reviewing

Statistics

Experience

Total positions 19

Experience in Healthcare 14.5 y

Avg length 1 y 9 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 ISO 27001 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

Profile

Created

June 2025

Last Update

June 2026

Need a freelancer? Find your match in seconds.

Try FRATCH GPT

Frequently asked questions

Have questions? Find more information here.

Where is Manuel based?

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

What languages does Manuel speak?

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

How many years of experience does Manuel have?

Manuel has at least 18 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.

What roles would Manuel be best suited for?

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 ISO 27001 implementation, External project manager for the global roll-out of a long-term storage solution.

What is Manuel's latest experience?

Manuel's most recent position is Overall project manager for the global roll-out of a quality and document management system at International medical device company.

What companies has Manuel worked for in recent years?

In recent years, Manuel has worked for International medical device company, Cloud services provider (AWS), Global pharmaceutical company, Software development company, and University Hospital St. Pölten.

Which industries is Manuel most experienced in?

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

Which business areas is Manuel most experienced in?

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.

Which industries has Manuel worked in recently?

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

Which business areas has Manuel worked in recently?

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

What is Manuel's education?

Manuel holds a Master in Technical Informatics and Applied Data Engineering from Vienna University of Technology.

Does Manuel have any certificates?

Manuel has 9 certificates. Among them, these include: Ima – Advanced Coaching: Leadership and Motivation of Managers, Ima – Train the Trainer, and Cobit5 Foundation.

What is the availability of Manuel?

Manuel is immediately available full-time for suitable projects.

What is the rate of Manuel?

Manuel's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.

How to hire Manuel?

To hire Manuel, click the Meet button on the profile to request a meeting and discuss your project needs.

Average rates for similar positions

Rates are based on recent contracts and do not include FRATCH margin.

1000

750

500

250

Market avg: 800-960 €

The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.

Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.

Similar Freelancers

Discover other experts with similar qualifications and experience

Experts recently working on similar projects

Freelancers with hands-on experience in comparable project as a Overall project manager for the global roll-out of a quality and document management system