Thomas Freudemann
Operational Excellence 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
Interim QC readiness project lead (04/23–05/23): defined and executed QC readiness workstream in site commercial manufacturing readiness program (Biopharma CDMO client, Heidelberg, Germany)
PMO for global QC team (01/23–03/23): established progress monitoring and reporting; designed and introduced reporting format, process and governance (Global Vaccine Biopharma client, Basel, Switzerland; remote)
QA Consultant
Actylis
Project lead for eQMS implementation project (MasterControl; modules doc & training)
Project lead for QMS harmonization project of legacy QMS for five sites in European countries
Created SOPs for new harmonized QMS
Trainer and system administrator for MasterControl go-live
Supported market release of nutraceuticals, fine chemicals and APIs
Head of Quality Unit
Swiss Caps GmbH / Aenova Group
Led site quality unit (50+ FTE in QA & QC)
Acted as ad-interim head of QA
Managed site quality remediation project and quality agreement remediation
Initiated and managed overdue CAPA remediation
Budgeted for quality unit and introduced lab capacity planning tool
Reported quality KPIs to local and global organization
Conducted quality board meetings and followed up on action items
Assessed compliance gaps and uplifted GMP level
Technology Consulting Principal
Accenture GmbH
Project leader for biopharmaceutical manufacturing IT/OT assessment and strategy (06/21–08/21; Global Biopharma client)
SME for pharmaceutical manufacturing in digital performance boards project: designed digital roadmap for continuous manufacturing line dashboard (02/21–05/21; Global Pharma client)
Established global MES system technical change management process and SOP (11/20–01/21; Global Biopharma client)
SME for pharmaceutical quality business processes in digital pharma greenfield reference plant (08/20–10/20)
Project manager for design transfer, design changes (CCB), service tools workstreams in international MedTech R&D project (~180 FTE; 05/19–07/20)
Provided ad-interim project governance for global MES implementation in pharma manufacturing plant (01/19–04/19)
Supported business development, sales and solution selling
Senior Consultant
Altran S.A.S. & Co. KG
Senior quality systems engineer for CAPA backlog and audit OBS remediation; introduced lean kanban board and process for CAPA and OBS management (09/18–12/18; Global MedTech client, Tuttlingen, Germany)
Quality systems engineer for DePuy Synthes: maintained local QMS, led inspection and test team (5 FTE), audit readiness, CAPA coordination, escalated quality issues (09/16–08/18; Plant Salzburg, Austria)
Provided consulting for utilities qualification project (08/16–09/16; Global Biopharma client, Vienna)
Supported sales in business closing and solution selling
Coordinated German PULSE knowledge sharing program and acted as single point of contact for biopharmaceutical industry client
Project Manager Operational Excellence, TechOps
Sandoz GmbH
Managed MES EBR rollout: deployed WERUM PAS-X MES for ~900 TechOps users; led cross-functional team (2–10 FTE), managed €2.4M budget, implemented hardware/software changes, end-user training and buy-in for electronic batch recording
Led lean transformation in sterile FDF production: led cross-functional team (5 FTE), implemented lean tools and processes on shopfloor, facilitated employee mindset change
Initiated and deployed Lean Six Sigma program in TechOps
Coordinated employee suggestion system in TechOps
Head Global Process Management, Business Unit Anti-Infectives
Sandoz GmbH
Provided technical support, performance monitoring and continuous improvement for Sandoz global manufacturing network anti-infectives (7 European sites, 1 Indian site)
Acted as change agent for global Lean Six Sigma deployment
Managed “Theoretical Limit in Energy Management” pilot project: feasibility study using McKinsey methodology; identified ~€500k p.a. energy savings with <2 years payback
Head IPC/QC Analytical & Technical Process Support Labs
Sandoz GmbH
Led 12 lab associates in IPC/QC and technical process support laboratory
Executed technical process improvement projects and introduced design of experiments for process optimization
Troubleshot API manufacturing processes
Performed analytics, QC and IPC of raw materials, intermediates, APIs and FDF; methods included pharmaceutical water analysis, HPLC, GC, GPC, UV/VIS, enzymatic, electrophoresis, Karl-Fischer
Served as occupational safety coordinator and SAP super user
Head Analytical Labs
Sandoz GmbH
Led eight lab associates in IPC/QC laboratory
Uplifted GMP level to inspection readiness
Released raw materials, intermediate products and redistilled solvents
Conducted analytics, QC and IPC of raw materials, intermediates, APIs and FDF; methods included water analysis, HPLC, GC, UV/VIS, enzymatic, physical characteristics, Karl-Fischer
Served as information security coordinator and SAP super user
Summary
- Over 20 years of experience in cGMP, Quality, Manufacturing, Operational Excellence, Project Management and Digital Transformation in the API, Pharmaceutical and MedTech industries.
Advancing Quality Excellence in Life Sciences
Skills
- Ms Office: Word, Powerpoint, Excel
- Project Management Software: Ms Project, Jira
- Plm / Technical Change Control Software: Polarion
- Business Process Software: Werum Pas-x; Sap R/3
- Statistical / Doe / Analytics Software: Minitab; Statgraphics; Stavex
- Laboratory Software: Lims
- Eqms Software: Etq; Trackwise; Mastercontrol; Veeva; D.3
- Edms Software: Agile; Dhc
Languages
Education
Distance University of Hagen
Diploma in Business Chemistry · Business Administration and Economics · Hagen, Germany · 2.5
University of Tübingen, Institute of Organic Chemistry
PhD in Natural Sciences · Analytical Chemistry · Tübingen, Germany · 1.0 (magna cum laude)
University of Massachusetts Amherst
Amherst, United States
Certifications & licenses
Qualified Person Austria (§ 7 AMBO)
AGES
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 17025 Lead Auditor
Exemplar Global
Manager Regulatory Affairs (Medical Devices)
TH & Uni Lübeck
Project Management Professional PMP
PMI
Quality Management Representative (QMR) ISO 9001-2015
OTL Akademie
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