19.11.2025 aktualisiert
100 % verfügbar
Manager (Head a.I. - Manufacturing/Operations/LdH, Quality/Corporate/QA/QMS/QC, EHS, QMB, QP/FvP), A
Wilen bei Wollerau, SZ, Schweiz
Weltweit
Dr. rer. nat., Dipl-Chem.Über mich
The enterprizes I haved worked appriciate - my competences and lead skills for pragmatic and sustainable solutions, for potentials, excellence, strategic holistic - my clarity, creativity, structured results , communication as part in the team - my claim to be a convincing ambassador for success
Skills
QMSFDAGMPBiotechProjekt ManagementEHSManufacturing QualitätssicherungFill & FinishCompliance CAPEXCQV
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
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
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Construction & CAPEX project (> 100 FTE), Fill & Finish/Lyo, Change Process, Lean Six Sigma, etc.