Norbert Helmke
Interim Project Manager Ramp-Up Pilot Facility
Experience
Interim Project Manager Ramp-Up Pilot Facility
BionTech
- Project management, control and follow-up of various issues in IT, SHE, technology, production, laboratory and supply chain
- Preparation of project management documents and moderation of project meetings
- Creation of documents in IT, SHE, technology, production, laboratory and supply chain necessary for start-up
- Support and optimization of administrative processes necessary for start-up
- Reporting to the Site Leadership Team and relevant stakeholders
- Claims management
Interim Program Manager
OPTIMA packaging group GmbH
- Scaling milestones and recruiting additional employees
- Setting up production lines together with the production manager
- Project management for the construction of complex pharmaceutical filling and packaging systems for international customers
- Managing machine projects holistically from order receipt to customer acceptance
- Technical and commercial clarification, creating project plans and monitoring key milestones
- Main contact for international customers and participating in customer meetings
- Responsible for site-specific project planning and execution, coordinating with line PM
- Coordinating with Contract & Controlling on legal aspects of contract management
- Ensuring profitability and customer satisfaction through project controlling, evaluating costs, quality and deadlines
- Controlling and coordinating project-related deadline claims
- Planning and implementing integrated lines at SHA and customer sites
- Single point of contact on site
- Claims management
- Executing validation and verification measures, FAT and SAT at customer premises
Program Manager
Gerresheimer AG
- Leading global industrialization projects from incoming orders to project completion per SOP PM001
- Clarifying project scope and creating project charter and deliverables list
- Managing qualification and validation strategies with customers and internal departments
- Creating project structure plan and defining work packages
- Actively leading and coordinating project teams, managing conflicts
- Planning project budget and invoicing deadlines (cash flow)
- Preparing and providing reviews and regular project reporting on margins, milestones and risks
- Main customer communication and stakeholder management
- Filing documents and ensuring GDP compliance
- Project controlling and monitoring milestones, commercial goals and risk minimization
- Managing and coordinating change management
- Claims management
Summary
I am an experienced interim manager and project manager with extensive expertise in strategic management processes, business strategy development, process management and change management. Specialized in quality management, budget management, supplier management and stakeholder management in highly regulated industries such as pharmaceuticals, medical technology and the automotive industry. Successful implementation of complex projects such as production and ramp-up processes, receivables management, GMP-compliant solutions and corporate identity launches. Comprehensive knowledge of project management tools (e.g. MS Project, Primavera) and SAP systems. Strong logical, strategic and customer-oriented thinking as well as the ability to efficiently manage several projects in parallel.
Skills
Interim Manager
Project Manager
Change Management
Process Management
Quality Management
Supplier Management
Budget Management
Stakeholder Management
Gmp
Sap
Pharmaceuticals
Medical Technology
Automotive Industry
Business Strategy
Production
Operations
Receivables Management
Team Leader R&d
Project Management (Ms Project, Primavera)
Quality Management
Risk Management
Change Management
Process Management
Supply Management
Budget Management
Production Management
Complaint Management
Operations
Claims Management
Responsible, High Degree Of Independence
Logical, Process-oriented And Strategic Thinking And Acting
Customer-oriented And Independent Working Style
Assertiveness And Strong Communication Skills
Good Understanding Of Mes And Lims
Team Oriented, Appropriate And Targeted Work
Organizational And Presentation Skills
Creativity And Design
Able To Manage Several Projects At The Same Time
Knowledge Of Core Business Systems (Sap)
Understanding Of Manufacturing Process Analytics
Good (Functional And Technical) Understanding Of Manufacturing Landscape And Requirements
Ability To Work In Regulated Environments With Knowledge Of Gxp Regulatory Documents Framework
Ability To Drive The Completion Of Activities Among Diverse Internal & External Stakeholders
Languages
Education
Technical Business Economist · Technical Business Economist
Technical College for Mechanical Engineering
Technical Engineer, with permission to instruct · Mechanical Engineering · Kassel, Germany
Certifications & licenses
Security Officer for Medical Devices
CATIA 5.0
TÜV Quality Representative (QMB) Part 2
TÜV Quality Representative (QMB) Part 1
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