Life Sciences Consultant - GMP, QMS, Projektmanagement, Quality

Establishing progress reporting and monitoring for Global QC team of an international Biopharma Vaccine MAH

Project Manager: Implementation of digital QMS
(MasterControl) and creation and deployment of harmonized
corporate QMS for Actylis Europe (5 countries)
MasterControl System Administrator (ad interim)
Market release of Nutraceuticals, Fine Chemicals and API's

Bad Aibling, Germany

Responsible for Site Quality Unit (50+ FTE in QA & QC)
Ad-interim Head of QA (vacant position)
Ongoing Site Quality Remediation Management
Ongoing Quality Agreement Remediation Project
Initiation and hands-on management of Overdue CAPA
Remediation Project; Reduction of count by approx. 20%
achieved in first month, mid-term strategy launched
Budgeting for Quality Unit
Lean QC efficiency project start-up, establishment of
production planning based forecast tool for QC workload
Staffing of vacant QA department roles and transition
planning for key roles due to ongoing QA reorganization
Quality KPI reporting for local and global organization
Conduct of Quality Board and follow-up on action items
Assessment of key compliance gaps and development of
strategy for sustainable uplift of GMP level with the long-term
goal to install a modern, efficient QMS and reach inspectionreadiness

Office Munich, Germany

Project Manager for biopharmaceutical manufacturing IT/OT
assessment and strategy project, Global Biopharma client
Subject Matter Expert for pharmaceutical manufacturing in
Project "Digital Performance Boards" - Design and digital
roadmap for a Continuous Manufacturing Digital Dashboard;
Global Pharma client




Consulting services: Establishment of a Global MES System
Technical Change Management process & SOP; Global
Biopharma Client
Subject Matter Expert for pharmaceutical quality business
processes (QA, QC, QMS) in internal Project "Digital
Pharma Greenfield Reference Plant"
Sub-Project Manager for workstreams Design Transfer,
Design Changes (CCB), Service Tools in a complex,
international MedTech R&D Project; Global MedTech Client
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

Consulting services: Senior Quality Systems Engineer -
Overdue CAPA & Audit Observation Remediation for Global
MedTech Client

Salzburg, Austria
Responsible for local QMS system implementation,
maintenance, and continuous improvement; coordination of
Quality Team Inspection and Test (4 FTE); audit readiness and
audit observation / CAPA coordination; investigation and
escalation of quality issues.

GmbH, Kundl, Austria
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 as follow-up of a McKinsey study:
Leading a cross-functional project team of approx. 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 and deployment in TechOps
Employee suggestion system coordinator for TechOps

Infectives, Sandoz GmbH, Kundl, Austria
Providing technical support, monitoring performance, and
driving continuous improvement initiatives and projects for
Sandoz Global Manufacturing Network Anti-Infectives (7
European sites, 1 Asian 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).

Sandoz GmbH, Schaftenau, Austria
People lead of 12 lab associates in a QC laboratory
Technical process improvement & 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.

Austria
People lead of 8 lab associates in a QC laboratory
Uplift of GMP level to ongoing inspection readiness
Analytics, QC, IPC of raw materials, intermediates, API'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.