Interim Manager

Responsibility: 
Implement and leading 9 work streams with approx. 50 members

Deliverables:

EU MDR 2017/745 requirements implementation in coordination with ISO 13485:216 and CFR 820 requirements.
Create detailed work plans, groups and sequences as well as prioritize activities needed to successfully implement the requirements  

• Develop resource plan 
• Define multiple work streams
• Set up score cards and KPI 
• Project controlling
• Weekly reporting /Score cards
• Implement project risk management and escalation procedures
• Set up and moderate workshops
• Support work stream members
• Manage the MDR requirement gap analysis and burn down chart
• Setup and report Management meetings and decision models    

Responsibility: 
Leading multiple work streams

Deliverables:

Coordination, identification within Regulatory Affairs and regional units’ timely implementation of all aspects and change of the China agent and every legally and regulatory required artefacts (License, Label &IFU) for medical devices Class II / IIb in the portfolio of +820 Products

• Regulatory Affairs / QM Management
• Multiple Work Streams
• Multi project management 
• Project controlling
• Weekly reporting /Score cards
• Success reports to Management

with other Business Lines, country organisations and the overall HQT/RA Management

Deliverables
Regulatory compliance & lean streamlining of “Production Control” processes

Class II Imaging Products
 

• GAP Analysis “Production controls requirements (ISO 13485:2016, 21CFR 820 QSR, MDR)
• Update DHF, DHR and suppling doc’s
• Risk Management / Risk Files 
  (ISO 14971 & MDR Preparation)
• Update & write qualification & validation policies and SOP’s:

Risk Management, Inventory, CSV, CS-Equipment, Data Integrity Calibration, Cleaning, Environment, Transport & Packaging 

• Advice on SW APPs and Tools 
• Advice on integrated IT production management (SAP / PLM / MES & interfaced App’s
• Advice on Cybersecurity (UL29000ff)
• Project & Team Matrix Management

Deliverables:

FDA GxP & Data integrity Gap analysis 

• Internal Audit / Gap analysis 
  ISO 14001,
  ISO 9001:2015 
  ISO 50001
  OHSAS 18001
  China GMP
  EU-GMP
  EU-GMP annex 11 
  FDA Data Integrity Audit &GAP
• cGMP, 
• GAMP5 Classifications
• Establish Computer System Inventory
• Execute risk analysis qualification & validation
• Local plant MES/CS System, Risk Based DI & Audit Trail categorization
• Define and write local leading VMP & CS-Validation, Qualification and Process Validation SOP’s 
• Lead DI/RA Team Meetings
• Lead general Validation & CSV policy and further steps
• Deliver final CS Inventory

Deliverables:

Remediation Project Leader Development 
RA Compliance

Sterile Barrier Systems & Non-Sterile Packaging Systems

Sterile Class II Products
 

• Design Development
• Studies, DoE’s 
• Risk Management / Risk Files 
  (ISO 14971 & MDR Preparation)
• Design verification & validation 
• Advise on QA & RA & 510(k) /CE Update and new registration
• Supplier Qualification (ASL & Legal)
•  Project & Supply Chain Budget 
• Team Matrix Management
• Design and execute Lab Tests 

Stability / Integrity Tests

Performance Tests

Microbial Barrier Tests

Interaction & Biocompatibility
ISO 11607, EN-ISO, BIS, DIN, ASTM, IEC, TIR, MIL Standards

• MDD to MDR Compliance
• Handling & Human Factors / Rolls 

Deliverables:

FDA GxP & Data integrity Gap analysis 

• Internal Audit / Gap analysis 
  ISO 14001,
  ISO 9001:2015 
  ISO 50001
  OHSAS 18001
  China GMP
  EU-GMP
  EU-GMP annex 11 
  FDA Data Integrity Audit &GAP
• cGMP, 
• GAMP5 Classifications
• Establish Computer System Inventory
• Execute risk analysis qualification & validation
• Local plant MES/CS System, Risk Based DI & Audit Trail categorization
• Define and write local leading VMP & CS-Validation, Qualification and Process Validation SOP’s 
• Lead DI/RA Team Meetings
• Lead general Validation & CSV policy and further steps
• Deliver final CS Inventory

Responsibility: 
Business Line: Digital Imaging, SYNGO
Leading multiple work streams and a team of over 30 internal employees.

Deliverables:

Coordination, identification within Regulatory Affairs view and timely implementation of all aspects and change of the Legal Manufacturer on every legally and regulatory required artefact for decelerated medical devices Class II in the portfolio for +120 Countries with budget responsibility

• Regulatory Affairs / QM Management
• Multiple Work Streams
• Multi project management 
• Project controlling
• Weekly reporting /Score cards
• Success reports to Management
• Resource management 
• Budget management & controlling
• Product re-registration in over 120 Countries
• Coordination with other Business Lines, country organisations and the overall HC-QT Executive PMO

Deliverables: 
Analyse and audit Product / Software design process from idea to finished product 

Improve process landscape 

• Analyze management process related to product design development / 3 management levels 
• Analyze Product management processes
• Analyse Software design &HFE processes and tools
• Analyze Software risk management processes / full live cycle
• Analyze Software QM management processes / full live cycle
• Analyze Software RA processes and compliance 
• ISO 9001 2015 Gap Analysis 
• ISO 13485 Audit
• ISO 14971 Audit
• IEC 62304 2015 Audit / HFE
• IEC 62366 2015 Audit/ HFE
• 510(k) Submission doc / process review
• Initialize & guide Improvement process

Deliverables: 
Implementation of Validation Policy into Present QM Policy

Execute SAP ECC System Validation

• MVP, VP, DQ, IQ, OQ, PQ, FR

Validation Strategy 

• IT Infrastructure
• Validation Strategy
• SOP Development
• Validation Master Plan Development
• GMP / FDA Compliance
• HFE Compliance
• CFR 820, CFR 820 part11
• Din ISO 13485

Policy and SOP’s

• Document Controls
• Change Controls
• Validation Master Plan, IT-Validation
•  Design Validation Template Documents for URS, FAT, SAT, VP, DQ, IQ, OQ, PQ, FR

• Multiple Work Streams
• Multi project management 
• Daily Huddle’s / Project controlling
• Weekly reporting /Score cards
• QPR / QSMRP preparation and presentation 
• Glass Wall’s & Huddle Boards
• Resource management over and for multiple sites
  Audit preparation
• Budget management & controlling

CAPA Subject Matter Expert / Interim Site CAPA Coordinator 

CAPA Initiation, Bounding/ Containment, Correction, Investigation
Root Cause Analysis, Corrective Actions, Preventive Actions, Rationales, 

• CAPA Remediation
• CAPA Review Board
• Root cause investigations in to all business an compliance /QSIT areas
• 5 Why’s, Ishikawa, D-FMEA, P-FMEA, HFE Risk management

• Packaging System
• HFE &Transport Test Simulation
• Test Method development for physical analytical Test Methods 
• Method Validation for physical analytical Test Methods 
• QM Master Validation Policy and SOP–design 
  Roll out of R&D Method Validation as a standard.
• Policy roll out
• Implementation and training
• Presentation 
• Combination Devices
• NIS, NIS AUTO, PEN 
• ISO 11608, MDD, cGMP, ICH, FDA RA- Guidance
• Human Factors Engineering 

• QM Master Validation Policy and SOP–design “Top down” roll out of the Corporate Quality Validation policy for all Group Members international as a standard.
   
• Packaging System
• Transport Test Simulation
• Test Method development for physical analytical Test Methods 
• Method Validation for physical analytical Test Methods 
• Labelling
• 
  Process / Equipment Validation
• -Software Validation CSV
• Method Validation
• Cleaning
• Sterile Barrier Packaging
• Sterilisation
• Packaging System
• Labelling
• Transport 
• Distribution
• Policy roll out
• Implementation and training
• Presentation 

• Company structure and organisation
• Vendor management
• Service management
• Management education
• Software solution consulting
• Human Factors Engineering Implementation and roll out 
• QM /QA Policy Implementation and roll out 
• QMH / Quality Management Handbook
   

GMP / FDA Compliance

• IT Infrastructure
• Network LAN Qualification Strategy
• SAN / SAP System (PP, PM, MM, QM) Validation strategy
• SOP Development
• Qualification Master Plan Development
• CFR 820, CFR 211, CFR 820 part11
• Din ISO 13485
• GMP / FDA Compliance
  • Integration present LAN / SAN infrastructure Systems
  • Integration present LAN / SAN infrastructure management Systems
  • Qualification Master Plan LAN /SAN
  • Change management LAN /SAN
  • SOP System LAN / SAN
  • SLA and standards LAN / SAN
  • Integration QM Policy
  • Integration QM System and Handbook
  • GxP Training Staff and management 

• Company structure and organisation
• Investment Management
• Vendor management
• Purchase Management
• Service management
• Management education
• Environment engineering
• Human Factors engineering  
• Software solution consulting
• QM/ QA Policy implementation and roll out