I am an experienced Interim Project Manager specialising in pharmaceutical and Medical Device production facilities

• Project management, control and follow-up of various issues in the areas of IT, SHE, technology, production, laboratory and supply chain
• Preparation of project management documents and moderation of project meetings
• Creation of documents from the areas of IT, SHE, technology, production, laboratory and supply chain that are necessary for the start of operations
• Support and optimization of administrative processes necessary for the start of operations
• Reporting to the Site Leadership Team and relevant stakeholders
• Project management, control and follow-up of various issues in the areas of IT, SHE, technology, production, laboratory and supply chain
• Assumption of a wide range of tasks and responsibilities in the commissioning of a pharmaceutical production plant, in the area of payment verification and document storage

Leadership of projects and programs (global industrialization projects with investment positions; projects which endure several phases of the product development process) regarding SOP PM001 from incoming orders to project completion.

• Clarification of project contents based on quotations/order documents/concluded contracts as well as creation of a project charter and deliverables list
• Management of elaboration of qualification-validation strategies with the customer and internal departments
• Creation of a project structure plan and definition of work packages for the specialist department
• Active leadership and coordination of project teams
• Active conflict management via moderating and solution orientated appearance
• Planning of project budget and deadlines for invoicing (Cash Flow)
• Preparation and provision of reviews (customer, gates)
• Regular preparation of project reportings regarding project margin/milestone tracking/project risks, and status of agreed project deliverables according to GX GMS handbook
• Active customer communication and primarily contact person for project relevant questions as well as management of customer communication between work package responsible person and customer
• Document filing and guarantee of GDP in the project
• Project controlling/monitoring of progress concerning milestones, commercial goals, risk monitoring/minimization
• Evaluation of decision-making tools for PSM/Management board in case of deviation
• Management and coordination of change management

• Interface role between research and development, business unit stakeholders and interfaces within Global Operations
• Responsible for coordination of external partners, purchasing, production, QC and logistics/distribution functions
• Technical management of operations project team
• Budget responsibility (CAPEX €180M, OPEX), result, time, supply chain, production and quality targets
• Implementation of development projects - developing drug forms from existing active substances
• Project management with interdisciplinary teams
• Creation of project plans, conducting meetings, milestone monitoring
• Regular project reporting and communication with customers
• Customer support including visits and on-site support
• Preparation of formulations in coordination with Product Development
• Support of up-scaling and transfer to commercial production
• Supplier monitoring and evaluation
• Ensuring continuous product and process quality based on specifications and standards
• API cooperation with QA, QC, production and formulation

• Professional management and coordination of interdisciplinary project team
• Control of timely and cost-effective implementation of major project milestones (CAPEX €220M)
• Customer support for project-related inquiries
• Creation of work packages and cost calculations in coordination with internal departments
• Cost control for project contract execution
• Development of process optimization and standardization concepts
• API cooperation with QA, QC, production and formulation

• Project management of complex devices for parenteral drug administration
• Technical responsibility for plastic components/systems development
• CAD design of medical components
• Project responsibility from concept through development to production handover
• Design documentation preparation
• Project team management and group-wide cooperation
• Test planning, coordination and evaluation
• Technical presentations internally and at customer sites
• Technical contact for internal projects and customers
• Coordination of 5 new plastic part tools
• Creation of packaging and labels
• Proactive cooperation on IFU and IQ/OQ/PQ documentation CAPEX €100,000

• Management of device and secondary packaging transfer/launch activities
• Leadership of BTDM PharmOps, Sandoz Biopharma and ESO project teams
• Interface with global functions including Device Development, TechOps, Regulatory and Supply Chain
• Responsible for launch/transfer of assembly and packaging processes
• Technical expertise for commercial operations during development
• Site selection analysis and recommendations
• Management of technical launch activities and timelines
• GMP and regulatory compliance assurance
• Member of Device Development, Validation and Supply Support teams
• Due diligence for licensing projects
• Manufacturing representation in device/packaging development
• Support for equipment design/qualification
• Process validation and robustness verification
• Quality and compliance management
• Risk analysis coordination
• Project budget responsibility (CAPEX €160M)

• Quality Management Manual design for ISO 13485:2016 and CE certification
• Development of RA and R&D documentation
• R&D process implementation
• CE and IVD documentation design
• Sub-project lead for IVD allergen instrument
• Compliance with:
• IVD-guideline 98/79/EC
• MDD 93/42/EEC
• DIN ISO 13485:2016
• ISO 10993

• Management of development and product change projects for incontinence management
• Material specification responsibility
• Technical documentation maintenance
• Supplier qualification and audit support
• External service provider management
• Product and material testing/analysis
• Product registration support (EU/Non-EU)
• Customer complaint assessment
• Patent monitoring
• Compliance with multiple ISO standards
• Quality processes implementation
• Material qualification and specification
• Production validation
• Change management
• Process verification

• Design History File remediation for FDA
• Resource planning and management
• Technical documentation oversight
• Document management
• Team leadership and development
• CAPA/NCR coordination
• FDA compliance (21CFR Part820)
• ISO standards implementation
• Process validation
• Sterilization oversight
• Protocol development
• Technical writing
• Medical device testing
• Quality systems management
• Regulatory interface

• Software change request management
• CAPA implementation
• Budget tracking and control
• Interdepartmental communication
• Performance monitoring
• Procedure compliance
• Customer requirements management
• Resource planning and allocation
• Software development coordination
• Technical documentation
• V-Model implementation
• Project planning
• Change/configuration management
• Risk management
• Quality systems oversight
• Multi-project management

• Project management and documentation
• Administration support
• HSE oversight
• Change management implementation
• Project controlling
• Measurement reporting

• SAP modules MM and SD implementation
• Project and procurement management
• Logistics oversight at Continental Teves

Self-service work at a confectionery manufacturer

Planning of curriculum, concepts, budget, calculation, acquisition, human resources and training

Design of grinding machines