Schlagwörter
Skills
Project Management, PMO, Computer System Validation, QMS, CSV, QA, GMP, Annex 11, CFR 21 Part 11, SOX, PMI, PMO, ITIL®, GAMP®, SOP, communication, Track & Trace, Serialisation
Projekthistorie
Company: Sanders & Associates GmbH
Position: Managing Director
Key focus of activities
Company: Tatkraft – Dr. Astrid Sanders
Position: Independent Consultant
Key focus of activities
Sabbatical
Company: sanofi-aventis
Position: Deputy Director IT Processes, Communication and Quality Management
Global responsibility / Managing executive / Member of global IT Management Board
Key focus of activities
Key Achievements
Company: sanofi-aventis
Position: Manager - Strategy, Portfolio and Quality Management
Global responsibility / Managing executive / Member of global IT Management Board
Key focus of activities
Company: Aventis
Position: Manager - Quality and Compliance / GxP Validation Leader
Global Management position
Key focus of activities
Key Achievements
Company: KPMG Consulting AG (today: bearingpoint)
Position: first consultant / soon senior consultant
Global Business Process Redesign and SAP R/3 Implementation
Summary of activities: Change Agent in the context of the global SAP implementation / Training of end users / On-boarding events and project marketing / Content Management Website and project communication
Position: Managing Director
Key focus of activities
- IT Project and Program Management
- IT Computerized System Validation
- Change Management / organizational changes
- Business/IT Processes optimization
- Communication / Coaching
- Quality Management System
- Project and Program Controlling
Company: Tatkraft – Dr. Astrid Sanders
Position: Independent Consultant
Key focus of activities
- Track & Trace
- Project Leadership and Management
- Computerized System Validation
- Quality Management
- Compliance /QA Auditor
- QA Interim Management
- Business/IT Processes optimization
- Communication / Coaching
- Change management and organizational changes
- Quality Management System and Manuals
Sabbatical
Company: sanofi-aventis
Position: Deputy Director IT Processes, Communication and Quality Management
Global responsibility / Managing executive / Member of global IT Management Board
Key focus of activities
- Company standards (cGMP, SOX etc.)
- Quality and Compliance Management (cGMP / SOX / ISO / ITIL)
- Internal audit und follow-up / Management of external audit activities
- Project Supervision (Methodology, Risk Management, Change Management, Quality Management)
- Internal communication, team building, conflict management
- Program and Project Management
- Internal business process design
Key Achievements
- Successful (in-time/in-quality/in-budget) global harmonization of working processes in the context of post-merger and implementation of a supporting IT system
- Development and implementation of a common GMP compliant Quality Management System
- Project supervision/coaching for more than 200 IT projects in 2007
- Development and execution of GMP compliance training
- Established efficient internal communication and collaboration
- Successful implementation of GMP and best practice related audit program
- Approved SOX, GMP compliance by external auditors
Company: sanofi-aventis
Position: Manager - Strategy, Portfolio and Quality Management
Global responsibility / Managing executive / Member of global IT Management Board
Key focus of activities
- Quality Management System (ISO 9000:2000 / 9001:2000 / GMP/ ITIL)
- IT strategy und project portfolio management
- Post-merger Communication
- Contractor‘s Management
- Team management - 6 team members located in London, Frankfurt, Bordeaux, Kansas City
- Established efficient global team, their training and qualification
- Development of the global IT strategy and implementation as basis of portfolio management
- Established Quality Management System (ISO, GMP, ITIL)
- Efficient communication in the context of the post-merger situation
Company: Aventis
Position: Manager - Quality and Compliance / GxP Validation Leader
Global Management position
Key focus of activities
- Quality Management and Project Methodology
- Training
- Project supervision – Project Methodology, Risk and Change Management
- Team Management - 2 team members located in Frankfurt
Key Achievements
- Transfer of an global expert team into an global department
- Training of appr. 350 individuals
- Implementation of an standardized way of delivering projects
- Implementation of a global Change Management Process
Company: KPMG Consulting AG (today: bearingpoint)
Position: first consultant / soon senior consultant
Global Business Process Redesign and SAP R/3 Implementation
Summary of activities: Change Agent in the context of the global SAP implementation / Training of end users / On-boarding events and project marketing / Content Management Website and project communication
Reisebereitschaft
Verfügbar in den Ländern
Deutschland, Österreich und Schweiz