Supporting a Medical Diagnostic Labs company in a Lean transformation program

Supporting the Lean Analysis Phase and establishment of tactical improvement plan

Interim Head of Quality Control acc. to AMG/AMWHV §12

Interim Management of QC Lab (30 FTE)

Interim Management of Analytical Development (5 FTE)

Start-up and Leadership of OOS Improvement Initiative

Support QC Readiness workstream in commercial readiness program (for uplift of GMP compliance, qualification of new QC lab, Anal. Method Transfer & Validation, QC Planning and scheduling system).

• Act as Global QC PMO to support client Global QC organization in managing relevant portfolio of projects and initiatives

• Project Lead for implementation of eQMS (MasterControl) and harmonization of QMS for Actylis EU (5 sites)
• Creation of harmonized SOP?s for QMS
• Trainer & System Administrator for MasterControl Go-live
• Market release of Nutraceuticals, Fine Chemicals and API?s

• 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
• 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 compliance gaps and uplift of GMP level 

2021-04 - 2021-07

• Project Manager for biopharmaceutical manufacturing IT/OT assessment project, Global Biopharma client 

2021-02 - 2021-04

• Subject Matter Expert for pharmaceutical manufacturing in Project ?Digital Performance Boards? ? Design and digital roadmap for a Continuous Manufacturing Digital Dashboard; Global Pharma client 

2019-10 -2019-12

• Consulting services: Establishment of a Global MES System Technical Change Management process & SOP; Global Biopharma Client 

2020-07 - 2020-07

• Subject Matter Expert for pharmaceutical quality business processes (QA, QC, QMS) in internal Project ?Digital Greenfield Reference Plant? 

2020-06 - 2020-06

• Sub-Project Manager for workstreams Design Transfer, Design Changes, Service Tools in a complex, international MedTech R&D Project; Global MedTech Client

2019-02 - 2019-04

• Consulting services: Ad-interim Project Governance for a Global MES Implementation Project in a pharma manufacturing plant in China (remote); 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

2016-09 - 2018-09

• Quality Systems Engineer for DePuy Synthes, Plant Salzburg, Austria, labor leasing contract

2016-08 - 2019-09

• Consulting service for Utilities Qualification Project; Global  Biopharma Client

• Sales support in business closing and solution selling
• German coordinator for Altran-internal international knowledge sharing transfer program (PULSE)
• SPOC for Biopharmaceutical Industry client (interviewing, staffing and placement of consultants)

• 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

• 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

2012-04 - 2013-01

• 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

• 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)

• 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

• 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
• Information security coordinator; SAP business super user