Thomas Freudemann
Operational Excellence Consultant
Experience
Apr 2024 - May 2024
2 months Wasserburg am Inn, Germany
Operational Excellence Consultant
amedes GmbH
- Operational Efficiency Assessment (with McKinsey)
Aug 2023 - Jan 2024
6 months Berlin, Germany
Interim Head of Quality Control
Advance Pharma GmbH
- Interim Head of Quality Control (AMG/AMWHV §12)
- Interim Management of QC Department (30 FTE)
- Interim Management of Analytical Development (5 FTE)
- Execution of plant efficiency roadmap for QC lab
- Start-up and Leadership of OOS Improvement Program
Jan 2022 - May 2023
5 months Zug, Switzerland
On-siteQC Strategy Consultant
Genioo
- As Interim QC Readiness Project Lead (04/23-05/23) for Biopharma CDMO Client, Heidelberg, Germany (on-site): Defined & executed QC Readiness workstream in site commercial manufacturing readiness Program.
- As PMO for Global QC team (01/23-03/23) for Global Vaccine Biopharma Client, Basel, Switzerland (remote): Established progress monitoring & reporting; designed and introduced reporting format, process and governance.
Feb 2022 - Dec 2022
11 months Düsseldorf, Germany
QA Consultant
Actylis
- Project Lead for 1. eQMS Implementation project (MasterControl; modules doc & training) and 2. QMS harmonization project of legacy QMS for 5 sites/QMSes in European countries
- Creation of SOPs for new harmonized QMS
- Trainer & SysAdmin for MasterControl Go-live
- Market release of Nutraceuticals, Fine Chemicals and APIs
Sep 2021 - Dec 2021
4 months Bad Aibling, Germany
Head of Quality Unit
Swiss Caps GmbH / Aenova Group
- Leadership of Site Quality Unit (50+ FTE in QA & QC)
- Ad-interim Head of QA (vacant)
- Ongoing Site Quality Remediation Project Management
- Ongoing Quality Agreement Remediation Project
- Initiation and management of Overdue CAPA Remediation
- Budgeting for Quality Unit
- Lab capacity planning tool introduction
- Quality KPI reporting for local and global organization
- Conduct of Quality Board and follow-up on action items
- Assessment of compliance gaps and uplift of GMP level
Jan 2019 - Aug 2021
2 years 8 months Munich, Germany
Technology Consulting Principal
Accenture GmbH
- As Project Leader (06/21-08/21) for a biopharmaceutical manufacturing IT/OT assessment and strategy project for a Global Biopharma Client.
- As SME (02/21-05/21) for pharmaceutical manufacturing in Project “Digital Performance Boards”: Designed and developed a digital roadmap for a Continuous Manufacturing Line Digital Dashboard for a Global Pharma Client.
- Provided consulting services (11/20-01/21) for establishing a Global MES System Technical Change Management process & SOP for a Global Biopharma Client.
- As SME (08/20-10/20) for pharmaceutical quality business processes (QA, QC, QMS) in the internal Project “Digital Pharma Greenfield Reference Plant”.
- As Project Manager (05/19-07/20) for workstreams Design Transfer, Design Changes (CCB), and Service Tools in a complex, international MedTech R&D Project (approx. 180 FTE) for a Global MedTech Client.
- Provided consulting services (01/19-04/19) for ad-interim Project Governance for a Global MES Implementation Project in a pharma manufacturing plant for a Global Biopharma Client.
- Business development, sales support, and solution selling.
Aug 2016 - Dec 2019
2 years 5 months Munich, Germany
Senior Consultant
Altran S.A.S. & Co. KG
- As Senior Quality Systems Engineer (09/18-12/18) for a Global MedTech Client, Tuttlingen: Managed CAPA Backlog & Audit OBS Remediation, and introduced a LEAN Kanban Board and Process for Management of CAPAs and OBS.
- As Quality Systems Engineer (09/16-08/18) for DePuy Synthes, Plant Salzburg, Austria: Responsible for local QMS system maintenance and continuous improvement, led Quality Team Inspection and Test (5 FTE), coordinated audit readiness and audit observation / CAPA, and investigated/escalated quality issues.
- Provided consulting services (08/16-09/16) for a Utilities Qualification Project for a Global Biopharma Client, Vienna.
- Sales support in business closing and solution selling.
- German coordinator for Altran-internal international knowledge sharing transfer program PULSE.
- SPOC (single point of contact) for Biopharmaceutical Industry client, including interviewing, staffing, and placement of consultants.
Apr 2012 - Jul 2016
4 years 4 months Kundl, Austria
Project Manager Operational Excellence, TechOps
Sandoz GmbH
- As Project Manager for the MES EBR Rollout Project, deployed the WERUM PAS-X MES system for approx. 900 TechOps end users. This involved leading a cross-functional project team of 2-10 FTE, managing a €2.4M budget, and implementing required hardware, software changes, end-user training & buy-in for electronic batch recording (paper-on-glass approach) in pharma manufacturing.
- As Project Manager for the TechOps Lean Transformation Project in Sterile FDF Production, led a cross-functional project team of 5 FTE to evaluate and implement various LEAN tools, methods, and processes on the shopfloor, driving employee mindset change and buy-in for LEAN principles.
- Initiated and deployed the Lean Six Sigma Program in TechOps.
- Coordinated the employee suggestion system for TechOps.
Nov 2010 - Mar 2012
1 year 5 months Kundl, Austria
Head Global Process Management, Business Unit Anti-Infectives
Sandoz GmbH
- Provided technical support, monitored performance, and drove continuous improvement initiatives and projects for Sandoz Global Manufacturing Network Anti-Infectives (7 European sites, 1 Indian site).
- Acted as Change Agent for Global Lean Six Sigma Program deployment in Sandoz Business Unit Anti-Infectives.
- As Project Manager for the “Theoretical Limit in Energy Management” pilot project at Sandoz Site Frankfurt (01-03/2012), conducted a hands-on feasibility study of McKinsey methodology, identifying and evaluating unknown levers for energy savings (approx. €500K p.a. potential identified with payback < 2 years).
Feb 2008 - Oct 2010
2 years 9 months Langkampfen, Austria
Head IPC/QC Analytical & Technical Process Support Labs
Sandoz GmbH
- Led 12 lab associates in the IPC/QC + Technical Process Support laboratory.
- Managed technical process improvement projects.
- Introduced Design of Experiments for Process Optimization.
- Troubleshot API manufacturing processes.
- Oversaw analytics, QC, IPC of raw materials, intermediates, APIs and FDFs, using analytical methods such as pharmaceutical water analysis, HPLC, GC, GPC, UV/VIS, enzymatic methods, physical characteristics, electrophoresis, and Karl Fischer.
- Served as Occupational Safety Coordinator and SAP business Super User.
Feb 2003 - Jan 2008
5 years Langkampfen, Austria
Head Analytical Labs
Sandoz GmbH
- Led 8 lab associates in the IPC/QC laboratory.
- Uplifted GMP level to ensure ongoing inspection readiness.
- Managed the release of raw materials, intermediate products, and redistilled solvents.
- Oversaw analytics, QC, IPC of raw materials, intermediates, APIs and FDFs, utilizing analytical methods including pharmaceutical water analysis, HPLC, GC, UV/VIS, enzymatic methods, physical characteristics, and Karl Fischer.
- Acted as Information Security Coordinator and SAP business Super User.
Summary
- +20 years of experience in cGMP, Quality, Manufacturing, Operational Excellence, Project Management and Digital Transformation in the API, Pharmaceutical and MedTech Industry.
Languages
German
Native
English
Advanced
French
Elementary
Spanish
Elementary
Education
Apr 2006 - Jan 2013
Distance University of Hagen
Diploma in Business Chemistry · Business Administration and Economics · Hagen, Germany · 2.5
Jan 1998 - Nov 2002
Institute of Organic Chemistry, University of Tübingen
Doctor of Natural Sciences · Analytical Chemistry · Tübingen, Germany · 1.0
Oct 1992 - Jan 1999
University of Tübingen
Diploma in Chemistry · Chemistry · Tübingen, Germany · 1.2
Certifications & licenses
ISO 13485 Lead Auditor
Exemplar Global
ISO 17025 Lead Auditor
Exemplar Global
Quality Management Representative (QMR) ISO 9001-2015
OTL Akademie
Diploma Applied Data Management
e-Learning Group
Lean Six Sigma Black Belt
Novartis/Valeocon
Qualified Person Austria (§ 7 AMBO) 2009
AGES
Certified Manager of Quality/Organizational Excellence CMQ/OE
ASQ
Certified Pharmaceutical GMP Professional CPGP
ASQ
Certified Quality Auditor CQA
ASQ
Manager Regulatory Affairs (Medical Devices)
TH & Uni Lübeck
Project Management Professional PMP
PMI
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