Thomas Freudemann
Life Science Consultant
Experience
Operational Excellence Consultant
amedes GmbH
Operational Efficiency Assessment (with McKinsey)
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
QC Strategy Consultant
Genioo
04/23-05/23: Interim QC Readiness Project Lead, Biopharma CDMO Client, Heidelberg, Germany (on-site) Define & execute QC Readiness workstream in site commercial manufacturing readiness Program.
01/23-03/23: PMO for Global QC team, Global Vaccine Biopharma Client, Basle, Switzerland (remote) Establish progress monitoring & reporting; design and introduction of reporting format, process and governance
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 SOP's for new harmonized QMS Trainer & SysAdmin for MasterControl Go-live Market release of Nutraceuticals, Fine Chemicals and API's
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
Technology Consulting Principal
Accenture GmbH
06/21-08/21: Project Leader for biopharmaceutical manufacturing IT/OT assessment and strategy project, Global Biopharma Client
02/21-05/21: SME for pharmaceutical manufacturing in Project "Digital Performance Boards" – Design and digital roadmap for a Continuous Manufacturing Line Digital Dashboard; Global Pharma Client
11/20-01/21: Consulting services: Establishment of a Global MES System Technical Change Management process & SOP; Global Biopharma Client
08/20-10/20: SME for pharmaceutical quality business processes (QA, QC, QMS) in internal Project "Digital Pharma Greenfield Reference Plant"
05/19-07/20: Project Manager for workstreams Design Transfer, Design Changes (CCB), Service Tools in a complex, international MedTech R&D Project (approx. 180 FTE); Global MedTech Client
01/19-04/19: Consulting services: Ad-interim Project Governance for a Global MES Implementation Project in a pharma manufacturing plant; Global Biopharma Client
Business development, sales support and solution selling
Senior Consultant
Altran S.A.S. & Co. KG
09/18-12/18: Senior Quality Systems Engineer – CAPA Backlog & Audit OBS Remediation for Global MedTech Client, Tuttlingen. Introduction of LEAN Kanban Board and Process for Management of CAPA's and OBS
09/16-08/18: Quality Systems Engineer for DePuy Synthes, Plant Salzburg, Austria: Responsible for local QMS system maintenance and continuous improvement; Quality Team Lead Inspection and Test (5 FTE); audit readiness and audit observation / CAPA coordination; investigation and escalation of quality issues
08/16-09/16: Consulting services for Utilities Qualification Project; 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 (interviewing, staffing and placement of consultants)
Project Manager Operational Excellence, TechOps
Sandoz GmbH
Project Manager for MES EBR Rollout Project: Deployment of WERUM PAS-X MES system for approx. 900 TechOps end users: leading a cross-functional project team of 2-10 FTE; managing 2,4 Mio€ budget; implementing required hardware, software changes, end-user training & buy-in for electronic batch recording (paper-on-glass approach) in pharma manufacturing
Project Manager for TechOps Lean Transformation Project in Sterile FDF Production: Leading a cross-functional project team of 5 FTE for evaluation and implementation of various LEAN tools, methods and processes on the shopfloor, employee mindset change and buy-in for LEAN principles
Lean Six Sigma Program initiation & deployment in TechOps Employee suggestion system coordinator for TechOps
Head Global Process Management, Business Unit Anti-Infectives
Sandoz GmbH
Providing technical support, monitoring performance, and driving continuous improvement initiatives and projects for Sandoz Global Manufacturing Network Anti-Infectives (7 European sites, 1 Indian site)
Change Agent for Global Lean Six Sigma Program deployment in Sandoz Business Unit Anti-Infectives
Project Manager for "Theoretical Limit in Energy Management" pilot project at Sandoz Site Frankfurt 01-03/2012: hands-on feasibility study of McKinsey methodology, identification, and evaluation of yet unknown levers for energy savings (approx. 500 k€ p.a. potential identified with payback < 2 years)
Head IPC/ QC Analytical & Technical Process Support Labs
Sandoz GmbH
Leader of 12 lab associates in IPC/QC + Technical Process Support laboratory Technical process improvement projects Introduction of Design of Experiments for Process Optimization Troubleshooting of API manufacturing processes Analytics, QC, IPC of raw materials, intermediates, API's and FDF's; analytical methods including e.g. pharmaceutical water analysis, HPLC, GC, GPC, UV/VIS, enzymatic methods, physical characteristics, electrophoresis, Karl-Fischer Occupational Safety Coordinator; SAP business Super User
Head Analytical Labs
Sandoz GmbH
People lead of 8 lab associates in IPC/QC laboratory Uplift of GMP level to ongoing inspection readiness Release of raw materials, intermediate products, redistilled solvents Analytics, QC, IPC of raw materials, intermediates, API's and FDF's; analytical methods including e.g. pharmaceutical water analysis, HPLC, GC, UV/VIS, enzymatic methods, physical characteristics, Karl-Fischer Information security coordinator; SAP business Super User
Summary
Academic degrees: Dr. rer. nat. (Analytical Chemistry); Diploma in Chemistry; Diploma in Business Chemistry
Competence: +20 years of experience in cGMP, Quality, Manufacturing, Operational Excellence, Project Management and Digital Transformation in the API, Pharmaceutical and MedTech Industry
Languages
Education
University of Vienna
Pharmaceutical Quality Management · Vienna, Austria
Distance University of Hagen
Diplom-Wirtschaftschemiker · Business Administration and Economics · Hagen, Germany · 2,5
University of Tübingen
Dr. rer. nat. · Analytical Chemistry · Tübingen, Germany · 1,0 (magna cum laude)
Certifications & licenses
Applied Data Management
CMQ/OE
CPGP
CQA
Certified Manager of Quality/Organizational Excellence CMQ/OE
ASQ
Certified Pharmaceutical GMP Professional CPGP
ASQ
Certified Quality Auditor CQA
ASQ
Diploma Applied Data Management
e-Learning Group
ISO 13485 Lead Auditor
Exemplar Global
ISO 13485:2016 Lead Auditor
ISO 17025 Lead Auditor
Exemplar Global
ISO 17025:2017 Lead Auditor
LSSBB
Manager Regulatory Affairs
Manager Regulatory Affairs (Medical Devices)
TH & Uni Lübeck
PMP
Project Management Professional PMP
PMI
QMR ISO 9001:2015
QP
Austria
Qualified Person Austria (§ 7 AMBO) 2009
AGES
Quality Management Representative (QMR) ISO 9001-2015
OTL Akademie
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