Curriculum Vitae

Skills, knowledge and experiences• Team leader R & D • Project manager software development rail vehicles • Project manager Pharma• Project manager Medical device • Project manager technical Medical device • Project manager ultraviolet light • Project manager (construction site responsibility) and HSE for chemical industry• Project manager logistics, production, supply chain automotive supplier industry• Project manager introduction of new corporate identity of automotive industry• Interim manager Managing Director • Projectmanagement • Qualitymanagement • Riskmanagement • Changemanagement • Processmanagement• Supplymanagement Budgetmanagement Productionmanagement Complainmanagement

Performance strengths

• Responsible, high degree of independence• Logical, process-oriented and strategic thinking and acting• Customer-oriented and independent working• Assertiveness and strong communicative skills• Team oriented, appropriate and targeted work• Organization and presentation• Creativity and design Able to manage several projects at the same time. Knowledge in core business system (SAP) Manufacturing process analytics understanding Good understanding (functional and technical knowledge) of manufacturing landscape and requirements. Abitlity to work in regulated environment with a GxP regulation documents framework knowledge Ability to drive the completion of activities among diverse internal & external stakeholders

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Norbert Helmkedate of birth: 10th April 1959

nationality: GermanGünter-Vogt-Ring 14a

60437 FrankfurtMobil: +49177/5856617

e-Mail: norbert.helmke@googlemail.com

Mobil: 0177/5856617

e-Mail: norbert.helmke@googlemail.com

05/2020 Balda Medical GmbH & Co.KG Senior Development Project Manager (contract)

• Project or subproject management of product developments of complex devices for parenteral drug administration

• Technical responsibility for the development of plastic components/systems for medical applications

• CAD design of medical components • Responsible for projects in the concept and development phase up

to handover to production • Preparation of design documents and their documentation • Management of project teams and cooperation in group-wide

project teams • Planning, Coordination/execution and evaluation of tests • Technical presentations internally and on-site at the customer • Contact for internal projects and at the customer for all technical

questions

07/2019 – 05/2020 Sanofi Frankfurt / Main (contract) Senior Technology Project Manager Task

• Lead project management activities during development, industrialization and transfers (international)• Support design transfer

• Hold technical leadership for nominated project team members• Escalation of critical issues and project decisions• Prepare and coordinate project meetings for assigned projects• Handover to Life Cycle Management and project closure• Track internal SPE (= budget approval) and purchasing orders• Updates financial information, e.g. CAPEX & OPEX• Establish and maintain relevant project documentation• Ensure and support transfer of the device master record• Ensure compliance with regulatory requirements/internal policies and support inspection readiness

05/2019 – 07/2019 Novartis Basel / Swiss (contract) Interim Director Project Manager Task:

• Lead project Teams (international)• Lead projects for the R&D department• Risk Management• Change Management• Presentation for the upper Management

Since 10/2018 – 04/2019 Novartis Basel / Swiss (contract) Device &; Packaging Transfer Team Lead

Professional Experience:Job Purpose (State in one sentence the overall objective of the role)Manages Device &; Secondary Packaging related to transfer and launch activities for assigned projects. Leads BTDMPharmOps, Sandoz Biopharma or ESO project team for transfer and launch project related to device assembly andsecondary packaging processes. Liaises efficiently with related global functions, in particular Device DevelopmentBTDM, TechOps, Regulatory and Supply Chain. Is responsible for successful launch / transfer of assembly and

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packaging processes from Development into Commercial operations and for the availability of launch supplies (intime and in required quantities).Major Accountabilities (Describe the 5-7 main results of the role to be achieved)

• Maximizes project value.• Provides technical expertise from commercial point of view, during device development stages and process commercilization• Supports Launch Site Decisions at e.g. PAC by providing analysis of technology, capacity, skills by performing interfunctional evaluations. Makes recommendation to PAC for assembly & packaging site selection.• Manages technical launch activities (process, technology, capacity, resources) for assembly and packaging at involved sites.• Defines and monitors project scope and timing.• Assures that all activities are performed acc. To current processes and standards (GMP, HSE, Regulatory). Ensures PAI readiness.• Is a member of the BTDM Device Development Subteam, Validation team and Supply Support team.• Performes Due Diligence initiatives and deal negotiations for selected in-license and out-license projects.• Act as a manufacturing representative during device development stages (design control)• Act as a manufacturing representative in the packaging design process for the BTDM product portfolio• Support site engineering in defining assembly & packaging equipment design / qualification related to transfer / launch products

Key Performance Indicators (Indicate how performance for this role will be measured)• No delay of milestones - meets agreed launch schedule.• Adheres to project / CAR costs and timelines.• Commercial form and SKUs (Stock Keeping Units).• Competitive TPC and complexity (number of SKUs) based on

business case.• Process robustness based on statistical evaluation.• No critical observations during internal GMP inspections and pre-approval inspections (PAI).

• Action plans from internal audits implemented; no delays in approvals.

Dimensions of the Job (Indicate key facts and figures)Number of staff reporting Direct: none Functional, indirect: noneLeads project team in matrix organizationFinancial responsibility(Budget, Cost, Sales, etc.)

04/2018 – 10/2018 Janssen Vaccines Bern / Swiss(contract)Technical Manager

POSITION SUMMARY: The Technical Manager has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace. 

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Areas of key responsibility include DP Packaging technical support and oversight for the supply chain, planning and execution of DP manufacturing site level support of new product launch. The Technical Manager is a member of manufacturing site operational teams, CMC DPD Subteam, and JSC New Product Team and leads the new production introduction team at the DP manufacturing site. 

Essential duties 

Tasks and Responsibilities • Provides or coordinates project management services for engineering and facility projects • Delivers project End-to-End, i.e. from shaping the idea, through capital appropriation, various design stages and subsequent execution as well as commissioning or qualification and final handover to the user • Applies state-of-the-art Project Management Standards • Provides subject matter or process expertise. • Uses technical knowledge of equipment and facilities maintenance systems as well as calibration standards, tooling processes and documentation control systems in a regulated manufacturing environment • Establishes a high performing team to deliver defined scope • Prepare routine status and progress reports • Lead the specification of functional and technical requirements and supports Procurement in negotiations with contractors and vendors • Establishes effective project planning and cost control (incl. hours) • Leads lesson learned workshops and fosters organizational learning 

Leadership tasks and personality aspects • Hands-on mentality, intrinsically motivated, excellent coordinator • Organize and direct multi-disciplinary teams effectively towards the project goal • Insure a safe working environment, esp. during construction and installation phases acc. to local EHS&S Guidelines • Supervise construction and machine installation • Ability to communicate effectively and unambiguously toward team, management, and suppliers • Communicates with all stakeholders and especially users regarding needs and leads the development of the user requirements specification. 

• Identifies shortfalls in affiliate resources and manages accordingly to safeguard project success. • Interfaces daily with site technical functions throughout project implementation. • Ensure accuracy and quality of all applicable deliverables• Supports the review and maintenance of consolidated URS• Support alignment of user requirements across topics/workstreams• Plan, Support and participate in informal user acceptance testing• Collaborate with vendor to ensure that user requirements are

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accurately interpreted and implemented• Collaborate and align with other Workstream Leads to ensure that the other workstream requirements are accurately interpreted and implemented

Competencies • Responsible staying within assigned project budgets and timelines as well as defined deliverables • Project-related supervision on GMP, EHS and SOx-compliance matters • IQ/OQ/PQ/PV• Quality Assurance, GMPs, Health Authority Regulations and

Validation practices/principles•Experience with internal and external audit principals.• Strong knowledge of GMP, GAMP, SOPs and quality systems. • Performance measurement • Strong knowledge of change control practices/strategies.• Acc. to defined project KPI’s 

SPECIFIC SYSTEMS: 

Document mgmt. systems such as DocSpace, Pharmadoc SAP, MS Office applications TrackWise Clarity Minitab or similar statistical software 

11/2017 – 03/2018 Allergopharma (contract)Project Manager QAS Medical Device Class IIa,b

Design and modification of Quality Management Manual for Certification of ISO 13485:2016 and CE Develop all Documents for RA and R&D

Process implement R&D Design of documents for CE and IVD Subprojectlead (IVD Allergeninstrument)

IVD-guideline 98/79/ECMDD 93/42/EECDIN ISO 13485:2016

ISO 10993 “Biological evaluation of medical devices”

08/2017 – 10/2017 Biedermann-Motech (contract) Business Process Manager Medical Devices Class III, ISO 13485

Development and improvement of existing production and development processes

Conception, design, implementation, testing and introduction of new processes

Construction Process Documentation Kanban Six Sigma

implants and screws of TitanValidation of design processesSterilization of instruments and implants from sub supplier Früh

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03/2017 – 08/2017 Paul Hartmann AG (contract)

Project Manager R&D Medical Device Class I

Management/coordination of development projects and product change projects in the area of Incontinence managementResponsibility for material product specification and their maintenanceProduction and maintenance of the technical documentation (Product Risk Management File, Design History File, Material and Product Specification etc.)Qualification of suppliers and accompanying the auditsSelection and assignment of external service providers (e.g., lab, developing packages, certificates, etc.) Test/analysis of materials, product patterns, ready products and competitive products and representation of the resultsSupport of the product registration processes (EU and Non-EU) by supply of the necessary dataAssessment of the customer complaints within the defined area of responsibility and if necessary initiating of measuresPatent assessments and observation of the market sphere

ISO 13485ISO 10993 “Biological evaluation of medical devices”CAPA ProcessISO 13485, 8.5 "Improvement"

21 CFR 820.100 "Corrective and preventive action“ Qualify of rough material Prepare of material specification Laboratory tests Production tests Qualify of finished products

Qualify of new suppliers Produce of hand samples

Change Management First production with new material and new supplier Verification of the raw material Verification of new products

08/2015 – 02.2017 DePuySynthes Zuchwil / Swiss (contract) Project Manager Manufacturing Process Information (MPI) and Quality Management, Class I, IIa, IIb Engineering Project Manager / CAPA Specialist

To work with Suppliers / Manufacturing Sites to document the process flowMonitoring performance by gathering relevant data and statistical reports

Manage CAPA/NCR activities, acting as a liaison between Quality Assurance and Manufacturing in the area of CAPA/NCR Liaise with other plants in the division to ensure that compliance to CAPA/NCR divisional and corporate requirements is achievedBuild positive relationships with customers and suppliersTo work with Suppliers / Manufacturing Sites to create the Production Risk Assessment

To work with Suppliers / Manufacturing Sites on the different requests coming from the Tech Files SME's

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To work with Suppliers / Manufacturing Sites to ensure ontime identification / escalation / mitigation of risks

To ensure on-time weekly status reporting To manage the projects in accordance with Company objectives. To work with Suppliers / Manufacturing Sites to ensure Project Commitments and Due Dates are met.

To manage the projects in accordance with Company objectives.To ensure health and safety of all internal end external employees working on his projects and that there is no impact as to quality.Responsible for the whole execution of the projects.That all current legal standards, GMP and compliance are met.Ensure that the excellent interdepartmental relationships are maintained with all other Company depts.Monitors are coaches the project team members to ensure that this objective is met.To maintain a continual focus on cost awareness.Manage project expense and all capital budgets.GxP experience, and knowledge of supplier Quality management and Quality auditing.Knowledge of GxP, ISO 13485and local quality regulatory

requirements.

Experience with ISO 14971 Experience with ISO 13485 CAPA Process implantation Process optimizing Complainmanagementimplants and screws of TitanValidation of design processesSterilization of instruments and implants from sub supplier Früh

10/2014 – 07/2015 Normed a Zimmer Company (contract)Project Manager / Team Lead DHF, Quality Management Class I, IIa, IIb

(Remediation of the Design History Files for the FDA) / CAPA Specialist

resource planning and supervision Technical documentationDocument managementLeading, developing, motivating and managing the work forceManage CAPA/NCR activities, acting as a liaison between Quality Assurance and Manufacturing in the area of CAPA/NCRWork with the FDA (21CFR Part820)Experience with ISO 10007Experience with ISO 14971Experience with ISO 13485ISO 10993 “Biological evaluation of medical devices”

510KCreation of Project plans and Milestone supervisioncarry out DHF remediation activities as per approved remediation planimplants and screws of TitanValidation of design processesSterilization of instruments and implants from sub supplier Früh

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develop protocols and procedurestechnical writing-reports and technical justificationdevelop understanding in functional / system testing of medical devicesGxP experience, and knowledge of supplier Quality management and Quality auditing.Knowledge of GxP, ISO 13485and local quality regulatory requirements.

Remediation for the FDAInterface for RAInterface for the QMDesign Control

04/2013 – 09/2014 Beckman Coulter Biomedical GmbH (contract)Project Manager / Sub Team Lead (Clinical Automation) and Quality Management, In-vitro-Diagnostikum (IVD)

In-vitro Diagnostic Directive (IVDD) or Directive 98/79/EC

resource planning and supervision Looking at ways to reduce waste and increase efficiencyTechnical documentationLeading, developing, motivating and managing the work force.Create, control, coordinate and manage an environment for effective and economic production of quality product.Document managementLead, direct and manage the communication between the departmentsGxP experience, and knowledge of supplier Quality management and Quality auditing.Knowledge of GxP, ISO 13485and local quality regulatory requirements.

Monitoring performance by gathering relevant data and statistical reportsFollow all company’s filed procedures and protocolsCooperate with other line managers and share information across the OrganizationComprehend customer requirements and make appropriate recommendations/briefings

Working with purchasing staff to establish quality requirements from external suppliersInterface for other Departments like EE, QA, Procurement, SoftwareCreation of Project plans and Milestone supervisionCoordination of construction, production, purchase, logistic.Setting up and maintaining controls and documentation proceduresDrawing InspectionMaking suggestions for changes and improvements and how to implement themConcept InspectionDesign InspectionValidation of the design processDocument reviewTechnical documentation for the FDAChange ManagementKaizenEMV

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FMEARisk Management (ISO 14971)Look for new supplierDBS LeadershipRequirement ManagementRequirement AnalysisExperience with ISO 13485

Experience with DIN EN 60601Design Controlworked with steel metal and aluminiumworked with cast ironworked with cast aluminiumworked with sheet metal

01/2012 – 04/2013 Bombardier

Project leader and Quality Management (contract)Software Change RequestCAPA SpecialistBudget trackingLead, direct and manage the communication between the departmentsMonitoring performance by gathering relevant data and statistical reportsFollow all company’s filed procedures and protocolsCooperate with other line managers and share information across the OrganizationComprehend customer requirements and make appropriate recommendations/briefingsPlanning, organizing and supervise the achievement of goals on different time scopes Manage the resourcesCoordination of software development, testing, quality, logisticLeading, developing, motivating and managing the work forceMaking suggestions for changes and improvements and how to implement themEngineering Budget RequestCreation of project plans and milestone supervision resource planning and supervision Technical documentationDocument managementV-ModellProjectplanning und ControllingTermin controllingBudget planningProgress controllChange- / Konfiguration-ManagementRisikomanagementMultiproject managementProgramm managementQuality management Tools (MS-Project) und MS-Office (Word, Excel, Powerpoint)Life ProjektmanagementDocument management

02/2011- 11/2011 XTREME Technologies GmbH Project leader and Quality Management (contract)

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Implementation and Optimization of processes Implementation of Configuration- and InstancemanagementQuality control of prototypes Supply managementCreation of Project plans and Milestone supervision Planning and performing of Power upgrades of different product linesCoordination of construction, production, purchase, logisticworked with steel metal and aluminiumworked with cast ironworked with cast aluminiumworked with sheet metal

07/2009 – 02/2011 Herrmann+Laux Personnel LeasingProject manager at Mammoet in Frankfurt: project management, documentation, administration back office, HSE, claim management, resource planning, change management, project controlling, measurement reports, claim managementworked with steel metal and aluminiumworked with cast ironworked with cast aluminiumworked with sheet metal

04/2009 – 06/2009 K Prüfservice GmbH Mannheim Head of Project coordination, administration, invoicing

03/2007 – 01/2009 Adecco Personnel Services - Frankfurt / Mainz Senior Project Manager Logistics at Continental Teves FrankfurtSAP module: MM, SDProject- and Procure Management / Logistics (start-ups) for a manufacturer of car equipment (automotive industry) Perform new plans Perform initial series of discussions with the relevant authorities Editing and continuing the fine-tuning of the project plan of start-up projects/deliveries with the subcontractors Creating Order demands for suppliers, and monitoring the dates and quantities Trigger the necessary production using lots of checklists Coordinating the in time delivery of customers Horizontal control of projects Development and implementation of presentations Process analysis of the logistical operations and development of new, efficient solutions Self-employed analysis and processing of complex issues through networking of data and information from different sources and areasSupply Chain ManagementProcurement

08/2006 – 03/2007 Distributions with an Automotive Manufacturer (Opel) Rüsselsheim. (Deadline coordination and auditing) SAP modules: SD, FI, MMCreate lists of priorities for Opel, Saab and Chevrolet Network planners. Follow-Up of VH master data, data collection, if necessary processing of dealer-data. Creation of Status Report on a monthly / weekly basis.

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Auditing and automatic release on OSIS Futures tracking of network planners and / or architects. Rejection clarification and completion in cooperation with Westiform / network planners and dealers. Deadline coordination between the Opel field service, architects and contractors. The focus here was on scheduling problems and the special care of remaining not convinced traders.

05/2004 – 07/2006 Independent RecruiterSAP module: SDDistribution of national personnel services, direct contact of potential candidates, candidate management. Recruitment of candidates, conducting interviews, and presenting candidates at the customer

01/2004 – 04/2004 Employed on a regular basis at MANPOWER GmbH Frankfurt/Höchst – Personnel Service:Misumi Europa GmbH (mechanical standard components supplier.). SAP module: MMMarketing assistant: responsible for the acquisition of new customers, implementation of new marketing strategies, fair planning and mailings, definition of new customer groups, creating of turnover and components reports.

01/2003 – 12/2003 self-service work at a confectionery manufacturer

07/2000 – 12/2002 Employed on a regular basis at IT-Services and Solution GmbH as Consultant for Lotus Notes and E-Commerce,Leader of the QM-Team, Leader of the back office, responsible for the budget, arrangement of travel and other project related events, co-ordination of workshops, managing the purchase order process, co-ordination of project meetings.

03/1999 – 06/2000 Employed on a regular basis at International Mail-Service GmbH:

Responsible for the VISIP Software tool (distribution),International user support (U.K., Belgium, Washington D.C., Singapore, Austria), purchasing of hardware,Cognos Impromptu reports (Oracle database), Ad-hoc Reports

11/1997 – 02/1999 Employed on a regular basis at MANPOWER GmbH Köln – Personnel Service:

WestLB and Aachener und Münchner Versicherung (insurance companies):

Support Agent – User Support Office 95/97, Windows 3.x and NT 4.0 Reutersterminal, Trade Wizard, Installation of Hard- and Software, Support of Exchange- und Management-Servers, Remedy Reports.CompuNet: Global user administrationDeutsche Bank: Technical consultant

04/1997 – 10/1997 Freelancer – nationwide system administration and user support at an insurance company and a bank for the operating systems Windows 3.1x / 95 / NT 4.0, MS Mail, Rumba 4.0, HobLink 3270, Novell 3.11 and 4.11

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01/1996 – 03/1997 General Manager and sales manager at media center Bonn GmbH, (planning of curriculum, concepts, budget, calculation, acquisition, human resources and training)

08/1994 – 12/1995 Trainer at media GmbH Stuttgart (Computer training (Office, PageMaker, AutoCAD 13, 3D-Studio, Microstation CAD, Windows 3.11 for Workgroups, Windows 95, DOS 6.2 and Windows NT)

10/1990 – 12/1993 Designer at Fa. SCHAUDT Schleifmaschinen in Stuttgart-Hedelfingen (grinding machines)

worked with steel metal and aluminiumworked with cast ironworked with cast aluminiumworked with sheet metal

07/1987 – 09/1990 Designer in the development department for air condition and radiators (tanks, trucks) at the SüddeutscheKühlerfabrik Julius Behr, Stuttgartworked with steel metal and aluminiumworked with cast ironworked with cast aluminiumworked with sheet metal

Education:02/2018 Security Officer for Medical devices10/2017 CATIA 5.0

12/2015 Qualitätsbeauftragter TÜV (QMB) Part 2

11/2015 Qualitätsbeauftragter TÜV (QMB) Part 1

09/2003 Correspondence degree course: eBusiness Manager

12/1999 – 01/2001 Correspondence degree course: Java Programmer

10/1997 – 121998 Correspondence degree course: Programmer(Software Engineering, programming languages QBASIC, C, COBOL)Degree: Programmer

04/1994 – 02/1995 Education for Technical Business Economist

1985 – 1987 Technical College for Mechanical Engineering at Kassel

03.06.1987 Degree: Technical Engineer with permission to instruct

1982 – 1984 Correspondence degree course at the Abendschule für Berufstätige in Kassel (night school). Degree: First public examination at secondary school

1974 – 1978 Education as precision engineer with IHK degree

1966 – 1974 Junior High School

Related Experience & Activities: 04/2015 - Prince2

- Scrum MasterSeite 12 von 14

03/2009 Training Six Sigma - Introduction in Six Sigma - Six Sigma Curriculum - Six Sigma Basic - Six Sigma Implementation - Six Sigma Project leading - Six Sigma Phase Define - Six Sigma Measure and Analysis - Six Sigma Improve and Control - Six Sigma Lead the Implementation - Six Sigma Green Belt - Six Sigma prepare Black Belt Projects

02/2009 Management Training for Leadership

Training for the Qualitätsmanagement - Quality management process - Tools for the Quality management - optimize of the company processes

Main Focus

Team Lead Projektmanager Projectmanager Requirements Engineer Changemanagement Riskmanagement Supplier Management

Technologie Know-how Operating Systems SUN Unix Windows NT Windows XP Networks

o Routero Networks TCP/IPo Routing (WAN/LAN)

Applikationen/Databasesystemso MySQLo MS Office (Word, Excel, Powerpoint, Visio, MS Project)o Clear Quest, Clear Caseo SmarTeamo Mirageo EPDMo Solid Workso SAPo Windchillo AGILEo Mango

Methods Consultingo Projektmanagemento ITIL (in general)

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o SIX SIGMA (in general)o Qualitymanagement (in general)o Kaizeno SCRUMo Agiles Management

Intersectoralo Controllingo Reporting

Special Skillso Business Prozesse

05/2004 PR and Marketing

11/2003 SAP (R/3 Rel. 4.6 c) Finance FI, CO, MM, SDBW (Presentation)

03/2003 Techniques of Meeting moderation

03/2003 Project coaching/-Supervision

03/2003 Project management (research studies)

03/2003 Project management (basis)

05/2002 IBM Global Services Method PM –Workshop

01/2002 WebSphere Commerce Suite: Store DesignIBM WebSphere Studio

12/2001 Internet and Security

07/2001 E-business: Designing Integrated SolutionsApplication Framework for e-business: Technology Workshop

06/2001 HTML Fundamentals

08/2000 Using JavaScript in Domino ApplicationUsing LotusScript in Domino Application

Web Application Fundamentals

07/2000 Domino Designer FundamentalsDomino Application, Security & WorkflowDomino Application Architecture

04/2000 Sun Solaris workshop

05/1999 Introduction in Reporting tool Impromptu ORBIS System administration for distribution and EDP

11/1999 Cognos Powerplay 6.5 administration

08/1998 Lotus Notes 4.5 administration

03/1997 Novell 4.x administration

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Additional Skills and Interests:

Languages: English (business), German (Mother tongue)French (basic)Italian (basic)Spain (basic)

EDV Windows NT, 98, 2000, XP, Office 2000, AutoCAD 12, 13, 14, 2000, Corel, Freehand,

Pagemaker, MS Project, Dreamweaver, Flash, Cognos Impromptu, Visio, Remedy, TCP/IP, Novel, Lotus Notes,

Education Lecturer at media center Bonn Ltd., Media Ltd. Stuttgart

Hobbies playing chess, reading, travelling, riding on a motorcycle, sailing, golf

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