Life Science Consultant

Operational Efficiency Assessment (with McKinsey)

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

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

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)

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)

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