Manager (Head a.I. - Manufacturing/Operations/LdH, Quality/Corporate/QA/QMS/QC, EHS, QMB, QP/FvP), Advisor&PM (Pharma, BioTech,...

Manager
SME
PM (CAPEX, Cross, Start-up/Construction, etc)
cGMP/GMP/13485/21 CFRxxx
FDA readiness
USP/DSP/SUT, F&F/RABS/Isolator/Lyo/VI, Granulation/Coating/etc.
QA/QC/QMS
EHS
IMS / Q-EHS
lean&shop floor (excellence)
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• CAPEX Projekte (TGA, Invest, Turnarounds)
• Fill&Finish, Abfüllung, Aseptic/Sterile Production
• Interim Management
• Leiter der Herstellung AMG / AMWHV
• Leiter Pharma Produktion, Quality, QA, QC, RP/QP
• Management Systeme (cGMP, GxP, 9001, 14001, 13485)
• Projektleiter
• Prozessmanagement
• Transfer (Produkte, Technik, Systeme, Methoden)
• Vacinnes, Biologics, RNS, API, Oncology, OTC, IMP

As Chemist and Industrial Expert I have profound and global experiences in the pharma, biotech, medtech, chemical industry since 1993 (Hoechst AG).
My SME competences are Manufacturing, EHS, Quality/QMS/IMS, Site developement, RM, QA/QC, CQV in compliance with international regulated requirements (i.a. cGMP/GMP/GxP, ICH/PIC, ISO 14644, MDR/IVDR, 21 CFR 210/211/820/etc, 14971/Q9, EHS, REACH/RoH, 13485, 9001, EFQM, 14001, 45001).
My competences, expertises as well as my leadership, analyzing, solution, team and integrating network skills are and have been the basic for my responsible projects, positions and mandates at Global Player, start-up, medium-sized companies (MAH/CDMO) like Roche, Janssen-Cilag, Sandoz, Acino Pharma, BioNTech, Lonza, Thermo Fisher Scientific, Recipharm, Catalent, Panpharma, RFS, WuXi Biologics, Alcon, Alstom, Hoechst, GETEC, Chem. Parks, etc. as:
•    Head and Manager Manufacturing/Operations/Production (LdH AMG/AMWHV)
•    Head and Manager Global/Corporate QA, QA/QC, QMS
•    Site Head EHS
•    QMB, FvP/QP, Compliance Officer, RP 52a AMG
•    Senior Project Manager, Advisor, Auditor, Trainer
My key expertises (DACH, EU, USA, Emergine, Asia, SA):
•    products (strategy, launch, scale-up, spin off, bring in market): biologic/biosimilar, API, drug (IMP, SM/LM, liquida, ATMP, solida, generica, OTC, vaccine, cosmetic), MDR/IVDR/combination, chemicals
•    site development: rump-up, construction, OpEx/Lean, organization, operations, EHS, quality, IMS/QMS, supply chain, transfer (site, products, technique)
•    project management (CAPEX, FDA readiness, OpEx/Best in Class/Six Sigma, cross/multiple, agile/scrum): lead all-phases, designing, RM, task/milestone/timeline, control, tracking, reporting
•    inspection&audit (lead, system, supplier, mock): Swissmedic, FDA (PAI/post, 483), EMA, ANVISA, MHRA, MDSAP, SRA
•    quality: strategy, standard, QMS/IMS, FDA, Q oversight, QA, deviation/CAPA/CC, Risk Management/FMEA, QC/analytic/lean-lab, MiBi, VI, AQL, mediafill, RA, releases
•    manufacturing: strategy, production/operations, MES, USP/DSP/f&f, VI, AQL, clinical/commercial/bulk, process validation, BRR, CQV, KPI/RFT, lean/SFM, CAPA, SCM
•    EHS: EHS/SGU compliance, organization, systems, sustainability, bio/process safety, road map, risk&safety management, EHS audit&inspection, EHS media, hygiene, REACH, risk/authority management
•    technique: (aseptic, vials/ampules/injectables, A-E): engineering, CQV, MSAT, URS, DQ-PQ/PPQ, PV, mediafill, plant/equipment, facility/utilities/HVAC, CAD, pilot/batch/conti, fermenter/bio, USP/DSP/SUT, RABS/isolator/ lyophilization, VI, granulation, extraction, coating, packaging

Industrieexperte, Senior Consultant, Interim-Manager (Geschäfts-/Betriebsbereiche, Quality/Produktion/Operations/Engineering, mit Ergebnis- und Personal- und Budget-Verantwortung, 160 FTE, 3-Schichtsystem), Projektleiter, Lead Auditor, Senior Trainer in der
- Biotechnologischen
- Pharmazeutischen
- Medical Device
- Chemischen
Industrie