Manuel Kathofer - Experienced Project Manager and Quality Manager

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Bad Häring, Austria

Experience

Jan 2024 - Present

1 year 7 months

Overall Project Manager

International Medical Technology Company

Took over overall project management after previous year’s rollout was halted
Root cause analysis and planning of new approach
Organized and ran qualification tests for the new software versions
Project planning and coordination of all tasks and assignments at six global sites and the software supplier
Compliance discussions with quality heads at the locations
Organized and led steering committee meetings to report to management
Successful go-live in fall 2024

Oct 2022 - Sep 2023

1 year

ISO27001 Implementation Project Manager

Cloud Service Provider (AWS)

Initial analysis gathering current and target state
Defined approach and step-by-step ISO27001 implementation
Conducted Stage 1 and Stage 2 audits
Certification achieved with no major or minor findings

Oct 2021 - Dec 2023

2 years 3 months

External Project Manager

Global Pharmaceutical Company

Organized and ran all rollout activities for a long-term storage solution for lab systems at four sites in Germany, Austria, 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 rollout phases
Reported to global and local steering committees while adhering to budget and timelines

Sep 2021 - Dec 2021

4 months

ISO9001 Implementation Project Manager

Software-Development GmbH, Rosenheim (DE)

Set up and implemented a quality management system under ISO9001:2015
Analyzed and optimized existing processes focusing on support, development, agile project management and Scrum
Identified measures needed for ISO9001 compliance
Defined SOPs and created the quality manual
Trained staff and the QMB
Prepared for external audits and supported certification audits

Feb 2020 - Jun 2020

5 months

ISO9001 Implementation Project Manager

Software-Development GmbH, Munich (DE)

Set up and implemented a quality management system under ISO9001:2015
Analyzed and optimized existing processes focusing on support, development and project management
Defined SOPs and created the quality manual
Trained staff and the QMB
Prepared and supported external audits for certification

Oct 2019 - Dec 2022

3 years 3 months

External Project Manager Data Integrity

Global Project

Developed approaches and methods for long-term archiving of critical lab and production data
Analyzed various source data formats and clustered application types
Archived raw data according to ALCOA+ principles using allotrope file formats
Created a global SOP for decommissioning different source systems and applied archiving solutions
Coordinated project teams in the USA (Fremont, Ridgefield), Germany (Biberach), Austria (Vienna) and China (Shanghai)

Sep 2018 - Nov 2021

3 years 3 months

External QM Officer and Validation Expert

University Hospital St. Poelten, Blood Bank UKP

Introduced and carried out all CSV methodologies under GAMP5 to validate computerized systems
Conducted GMP training and briefed lab and IT staff
Organized all validation processes: infrastructure, lab equipment qualification, software application validation, and quality assurance and control
Applied to subprocesses: appointment scheduling, donation management, lab analyses, production, reporting and storage

Mar 2017 - Jul 2019

2 years 5 months

Senior Device Development Consultant

Sandoz GmbH, Schaftenau (AT)

Created, supplemented and expanded regulatory documentation (DHF, DMR) for medical devices and combination products for EU and US markets under 21 CFR 820
Internal change control manager for development and commercialization products
Coordinated between QA, QC, packaging and development for projects including etanercept and adalimumab (needle-safety device, autoinjector)

Feb 2017 - Dec 2017

11 months

Data Integrity Consultant QC Processes

Boehringer Ingelheim, Biberach (DE)

Analyzed and assessed GMP-validated lab applications against ALCOA+ requirements
Created process data maps and a data integrity implementation plan for biopharma
Delivered training on creating process data maps
Reviewed and evaluated manufacturing and LIMS processes for GMP compliance
Conducted risk assessments using FMEA and defined measures to meet compliance

Jan 2017 - May 2017

5 months

ISO9001 Implementation Project Manager

Transport and Logistics Company (Western Austria)

Set up and implemented a quality management system under ISO9001:2015
Analyzed, adapted and optimized existing processes
Defined SOPs and created the quality manual
Trained staff and the QMB
Prepared and supported external audits for certification

Apr 2016 - Dec 2016

9 months

IHE Communication Platform Project Manager

IT Healthcare Company, Wels (AT)

Project planning, effort estimation and team coordination
Sprint planning and status meetings to implement an IHE-compatible networking platform for healthcare providers
Used Orchestra® as the implementation platform
Defined milestones for developing various IHE handlers

Apr 2015 - Oct 2016

1 year 7 months

Overall Project Manager DWH Implementation

Austrian Red Cross Upper Austria

Introduced a cross-generation DWH solution based on MS SQL Reporting Services
Data transfers from SAP IS-H, FI/CO, HR and other applications
Phased out legacy systems including historical data migration
Built datamarts and data structures and implemented a permissions system via Active Directory

Jun 2014 - Nov 2014

6 months

ISO9001 Implementation Project Manager

Optical Components Development and Manufacturing Company (AT)

Set up and implemented a quality management system under ISO9001
Analyzed existing processes and identified measures needed for ISO9001 and ISO14001 compliance
Defined SOPs and created the quality manual
Trained staff and the QMB
Supported internal audits and TÜV certification for ISO9001:2015 in summer 2016

Aug 2013 - Dec 2013

5 months

ISO9001 Implementation Project Manager

Engineering and Plant Development Company (AT)

Set up and implemented a quality management system under ISO9001
Analyzed existing processes and identified measures needed for ISO9001 compliance
Defined SOPs and created the quality manual
Trained staff and the QMB
Supported external and internal audits
Planned extension to ISO9100 for aerospace suppliers

Jun 2011 - Dec 2016

5 years 7 months

Overall Project Manager NMS Implementation

Austrian Red Cross Upper Austria, Blood Center Linz (AT)

Introduced and GMP-validated new medical software (NMS) for appointment scheduling, donation management, lab analyses, production, reporting, storage, distribution and billing in SAP
Designed and implemented innovations: reagent management, biobank, sample management, lab production system, data archiving
End-to-end batch tracking according to cGMP regulations
Restructured project after halt, reorganized team, led project team
Phased out LIMS and redesigned lab IT architecture
Integrated and GMP-qualified lab automation; handled internal and external audits (AGES)
Milestone planning, project controlling and reporting to the supervisory board

Jun 2011 - Mar 2015

3 years 10 months

Overall Project Manager Central Billing

Austrian Red Cross Upper Austria

Introduced a new system solution for administration and billing of all rescue and patient transports
Created solution concept and tender documents for vendor selection
Conducted tender and proposal evaluation for management
Implemented SAP IS-H with interfaces to third-party applications (emergency doctor documentation, ELGA)
Specified and developed a Win8 app for mobile use in rescue vehicles (eCARD reading, emergency doctor deployment documentation)

Mar 2011 - May 2011

3 months

Blood Batch Tracking Consultant

University Hospital Tübingen (DE)

Created a hospital-wide target concept for blood batch tracking under transfusion law
Analyzed current processes and documentation status on wards
Process analysis for blood bank and pharmacy and modeled delivery and administration
Defined feedback processes for patient-related billing
Created requirements catalog, user requirements and solution concept and supported vendor selection

Nov 2008 - Mar 2010

1 year 5 months

Vice President Global Project Management

EXTEDO, Munich (DE)

Responsible for global project management with 80 staff across UK, US and Japan
Implemented submission management systems (eCTD) at pharma companies and authorities (EMA, SwissMedic)
Managed clinical studies in regulatory submissions (EU, FDA)
Established CRO consulting services and pharmacovigilance solutions
Workflow solutions for ICSR and SUSAR reports with the EMA
Validation planning and execution under GAMP5
Expanded services to include regulatory consulting and validation workshops
Implemented DMS systems, infrastructure and data security concepts

Jun 2008 - Mar 2011

2 years 10 months

Quality & Risk Manager

EXTEDO, Munich (DE)

Developed and maintained an ISO9001:2008-based, GAMP5-compliant QM system
Introduced and optimized SOPs and conducted internal and external audits for ISO9001 and GMP compliance in CSV
Created QM reports and rolled out the QM system to other sites (Philadelphia, Birmingham)
Risk management and software risk assessments
Planned and executed system and application validations under GMP/GAMP5
Prepared standardized validation documentation (IQ, OQ, PQ) and templates
Advised clients on validation requirements and supported external audits

Jan 2008 - Dec 2010

3 years

Managing Director

AFreeze GmbH, Innsbruck (AT)

Transitioned cryotechnology from preclinical phase to series production
Implemented and certified EN13485
Defined and standardized all company processes
Conducted audits with certification bodies and expanded the QM system
Winner of the 1st Tyrol Cluster Award for internal innovation

Summary

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
Since 1998 part-time lecturer at FH Kufstein for business informatics, ERP systems and business process management, currently in the master’s program
Lectures “Applied Quality Management”, “Practical SW Quality Management”, “GDPR Implementation and Application”, “Fundamentals of IT Security”
UMIT Private University for Health Sciences, Medical Informatics and Technology – lecturer for GDPR and IT security
IT companies: service providers, software, application and product manufacturers, consulting firms
Life Sciences industry: CSV validations, GMP, infrastructures, applications, production lines, archiving of lab and production raw data according to data integrity/ALCOA+ regulations, conversion to allotrope file formats, LIMS applications, blood bank systems, batch tracking systems, equipment qualifications, medical device and combination product approvals, eHealth solutions and strategies, ELGA integrations, IHE, HL7, eFA (electronic patient records), GEMATIK infrastructure integrations
Pharmaceutical industry
Blood banks, tissue banks
Manufacturing industry, manufacturers/suppliers of medical technology products
Logistics companies, food producers, hardware store chains (baumax-x)
Manufacturing companies, production facilities