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 and 11 months . 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 Technology Company .

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

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

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 (IT) , Transportation and Logistics , and Aerospace and Defense .

Q: Which business areas is Manuel most experienced in?

Manuel is most experienced in business areas like Quality Assurance (QA) , Project Management , and Information Technology (IT) . Manuel also has some experience in Accounting , Production/Manufacturing , 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 (QA) , and Information Technology (IT) .

Recommended expert

Bad Häring, Austria

Experience

Jan 2024 - Present

2 years 2 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 last year's rollout was canceled
Identified causes and planned the new approach
Organized and conducted qualification tests for new software versions
Planned and coordinated all tasks and assignments across six global sites and with the software vendor
Aligned compliance topics with the quality heads at the sites
Organized and held steering committee meetings to report to senior management
Successful go-live in fall 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
Defined the approach and phased ISO27001 implementation
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 carried out all roll-out activities at four sites in Germany, Austria, the USA, and China
Performed project scoping phases to identify and classify all target systems
Planned the project, allocated tasks and roles, and organized and executed the execution phases
Reported to global and local steering committees
Ensured compliance with budget and timelines

Sep 2021 - Dec 2021

4 months

Project Manager for ISO9001 Implementation

Software Development GmbH

Built and implemented a quality management system according to ISO9001:2015
Analyzed and optimized existing processes with a focus on support, development, agile project management, and Scrum
Identified necessary actions to achieve ISO9001 compliance
Defined SOPs and created the QM manual
Trained staff and the quality manager and prepared for external audits
Supported audits and achieved certification

Feb 2020 - Jun 2020

5 months

Project Manager for ISO9001 Implementation

Software Development GmbH

Built and implemented a quality management system according to ISO9001:2015
Analyzed and optimized existing processes with a focus on support, development, and project management
Identified necessary actions to achieve ISO9001 compliance
Defined SOPs and created the QM manual
Trained staff and the quality manager 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 various source data formats of the applications and systems to be replaced
Clustering application types and developing archiving strategies according to ALCOA+ principles
Evaluation and selection of potential target systems for long-term archiving
Implementation using alternative file formats
Creation of global SOPs for decommissioning 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 Officer and Validation Expert

St. Pölten University Hospital

GMP validation expert and external quality management consultant for the introduction of a new blood bank software
Implementation and execution of CSV methodologies according to GAMP5
GMP training and briefing of lab and IT staff
Organization of all validation processes: infrastructure, qualification of lab equipment, validation of software applications, quality assurance and control
Application to all subprocesses: appointment scheduling, donation management, lab analysis, reporting, production, and warehousing

Mar 2017 - Jul 2019

2 years 5 months

Senior Device Development Consultant

Sandoz GmbH

Creation, supplementation, and extension 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 commercial products
Interface function between departments such as QA, QC, packaging, and development
Support for multiple projects, including various delivery forms of etanercept and adalimumab (needle safety device, autoinjector)

Feb 2017 - Dec 2017

11 months

Data Integrity Project Manager in QC Processes

Böhringer Ingelheim

Analysis and assessment of all GMP-validated lab applications against ALCOA+ requirements
Creation of process data maps and a data integrity implementation plan for biopharma
Alignment of process data maps for various QC processes
Training participants on creating process data maps based on requirement documents
Review and assessment of manufacturing and LIMS processes for GMP compliance according to ALCOA+
Conducting FMEA risk assessments
Definition and evaluation of 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, adaptation, and optimization of existing processes
Definition of SOPs and creation of the quality manual
Training 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 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 for connecting healthcare providers with Orchestra®
Definition of milestones for developing the various IHE handlers
Coordination of 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
Replacement of legacy systems, including migration 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 ISO9001 Implementation

Optical Components Development and Manufacturing Company

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

Aug 2013 - Dec 2013

5 months

Austria

Project Manager for ISO9001 Implementation

Engineering and Plant Development Company

Development and implementation of a quality management system according to ISO9001
Definition of SOPs and creation of the QM manual
Training of employees and the QMB
Preparation and support of external audits for certification
Planning the extension to ISO9100 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 the introduction and GMP validation of the New Medical Software (NMS) for all subprocesses
Design and implementation 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 project halt, restructuring and personnel reorganization
Setup and validation of a LIMS and redesign of the IT architecture
Integration and GMP qualification of lab analyzers (Architect, Prism, Sysmex, Cobas) and external clients (HL7)
Establishment of GMP-compliant QM documentation structure and execution of internal and external audits
Support for restructuring the IT department and coordination of external service providers
Milestone planning, project controlling and reporting to the project advisory 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 manage and bill emergency and patient transports
Developing the solution concept and tender documents
Managing the tender process and evaluating proposals
Implementing SAP IS-H with interfaces to third-party applications (emergency physician documentation, DaMe, ELGA)
Specifying, developing, and commissioning Win8 apps for mobile use in emergency services

Mar 2011 - May 2011

3 months

Tübingen, Germany

Consultant for Blood Bank Processes

University Hospital Tübingen

Developing a hospital-wide target concept for blood batch tracking according to the Blood Transfusion Act (TFG)
Conducting an as-is analysis of workflows and documentation status on the wards
Analyzing processes in the blood bank and pharmacy, including modeling of delivery and administration processes
Defining feedback processes for patient-related billing
Creating a requirements catalog, user requirements, target process, and system specifications
Supporting the vendor selection process

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 QMS
Implementing new and optimizing existing SOPs, and conducting internal and external audits
Risk management and software risk assessments
Planning and executing validations in software development processes (categories 3–5)
Standardizing IQ, OQ, and PQ, and creating templates for validation documentation
Rolling out the QMS to sites in Philadelphia (USA) and Birmingham (UK)
Implementing eCTD-based submission management systems for authorities and companies
Building consulting services for CROs and pharmacovigilance solutions
Responsible for customer support and expanding regulatory consultancy services
Designing DMS infrastructure, VPN access, and terminal server architectures
Contributing to the business continuity 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 to EN13485 – 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

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Healthcare (14 years), Pharmaceutical (9.5 years), Manufacturing (3 years), Information Technology (2 years), Transportation (0.5 years), and Aerospace and Defense (0.5 years).

Healthcare

Pharmaceutical

Manufacturing

Information Technology

Transportation

Aerospace and Defense

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (16 years), Project Management (15.5 years), Information Technology (11 years), Accounting (4 years), Production (3 years), and Product Development (2.5 years).

Quality Assurance

Project Management

Information Technology

Accounting

Production

Product Development

Skills

Professional Focus Areas

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

Professional Competencies

Corporate Management / It Project Management: Project Planning, Scheduling, And Execution Of Complex It Projects, Leading Teams In Diverse Tasks: Infrastructures, Implementation Of Software Applications, 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, Elga/ehealth, Pharmaceutical Manufacturing, Etc.
Mission-critical Projects: Database Replications Across Multiple Sites, 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 According To Selectable Qm Standards
Improvement And Optimization Of Development Processes In Software And Hardware: Reducing Warranty Cases, Rework, And Support Loads
Restoring Process Control, Documenting Legacy Systems
Restoring Profitability, Billing Of Services
Implementing Quality Management And Compliance According To 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, Procedures, And Responsibilities
Audit Preparations, Conducting Internal And External Audits, Certification Audits, Representing Organizations To Authorities, Clients, Or Certifiers
Project Management, Controlled & Efficient Development Processes
Planning And Automation, Optimization Of Production Processes And Controls (Mainly Process Engineering)
Interfaces With Erp Systems, Production Planning Systems For Material Usage Calculations And Optimization Tasks
Implementing And Improving Qm Systems According To Iso9001:2015, Cmmi, Gdpr, En13485 Medical Technology, Design Controls 21 Cfr 820.30, Gamp5, Gmp, Csv (Computer System Validation), Cfr21 Part11, Data Integrity, Pic/s Guide
Special Knowledge In Fail-safe And Safety-critical Systems Iec 61508
Audit Preparations, Organization And Execution Of Internal And External Audits By Authorities Or Mission-critical Clients
Trainings, Teaching Basics, Applications, And Best Practices
Raising Awareness, Reorganizing Responsibilities, Supporting Change Processes (Change Management)
Corporate Management, Business And Budget Planning, Recruiting And Building Teams, Developing New Business Areas
Planning And Executing Mergers And Acquisitions
Finding Investors And Company Financing
Interim Management As Managing Director, Vice President, Department Head, Quality And Risk Manager
Project Lead In Especially Mission-critical Projects
Building, Reorganizing, And Securing Success In Sales And Development Departments
Preparation, Execution, And Securing Of Acquisitions/mergers Both Personnel And Financial

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, 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 Engineer in Technical Computer Science and Applied Data Technology · Technical Computer Science and Applied Data Technology · Vienna, Austria

Certifications & licenses

Ima – Advanced Coaching: Leadership and Motivation of Managers

Ima

Ima – Train The Trainer

Ima i.e. "Institute for Management Altran"

Cobit5 Foundation

EN13485 – Medical Technology

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

Irca ISO9001:2015 Auditor

Validation of computerized systems according to GMP/GAMP5

Certified GDPR Consultant

eCTD Submissions and Reviewing

Profile

Created

June 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

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 and 11 months. 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 ISO27001 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 Technology Company.

What companies has Manuel worked for in recent years?

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

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 (IT), Transportation and Logistics, and Aerospace and Defense.

Which business areas is Manuel most experienced in?

Manuel is most experienced in business areas like Quality Assurance (QA), Project Management, and Information Technology (IT). Manuel also has some experience in Accounting, Production/Manufacturing, 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 (QA), and Information Technology (IT).

What is Manuel's education?

Manuel holds a Master in Technical Computer Science and Applied Data Technology 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

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Market avg: 850-1010 €

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.

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