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I am an interim manager and have worked for the last 12 years as a project manager/ program manager in various business
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Work Background
OPTIMA packaging group GmbHInterim Program Manager
Oct. 2023Schwäbisch Hall, Baden-Württemberg, Deutschland · On-site• Project management for the construction of complex pharmaceutical filling and packaging systems for international customers, first point of contact and manage customer activities with the support of the specialist departments.
• Processing of machine projects holistically from order receipt to acceptance by the customer. Central contact for all parties involved.
• Technical and commercial clarification. Creation of project plans and monitoring of relevant milestones.
• Main contact for international customers.
• Participation in customer meetings. Plan and lead internal project team meetings with all participants.
• Responsibility for site-specific project planning and execution, taking into account personnel and production capacities in coordination with the line PM.
• Coordination with the project management Contract & Controlling to check the legal aspects in contract management and to prepare additional necessary offer supplements.
• Ensuring profitability and customer satisfaction through project controlling, evaluating costs, quality and deadlines and reporting to the portfolio manager.
• Control and coordinate project-related deadline claims and coordinate with the relevant interfaces.
• The creation and monitoring of the specified schedule and, if necessary, the initiation of measures is the responsibility.
• Responsible as an interface between the individual departments for monitoring the error analyses and their corrections.
• The planning and implementation of integrated lines in SHA and at the customer’s site.
• Planning and implementation of contribution concepts.
• Manage, plan and report the open points.
• SPOC (Single Point Of Contact) on Site
GerresheimerInterim Programm-Manager
Mar. 2023 - Sep. 2023Wackersdorf, Bayern, Deutschland · On-siteLeadership of projects and programs (i.e. global industrialization projects
with investment positions; projects which endure several phases of the
product development process) regarding SOP PM001 from incoming orders
(order explanation) 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 the 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, as well as the status of agreed project deliverables
according to GX GMS handbook.
• Active customer communication and primarily contact person regarding
every project relevant questions as well as management of the customer
communication* between work package responsible person and customer*
(stakeholder with internal projects) • Document filing and guarantee of GDP in the project
• Project controlling/monitoring of the project progress concerning milestones,
commercial goals, risk monitoring/minimization.
• In case of deviation Evaluation of decision-making tools for
PSM/Management board
• Management and coordination of change management
avateramedical GmbHInterim-Projektmanager
Jul. 2022 - Dec. 2022Ilmenau, Thüringen, DeutschlandInterface role between Research and Development, the relevant stakeholders of the Business Area as well as all relevant interfaces within Global Operations.
• Within Global Operations responsible for the coordination of all functions from external partners, purchasing, production, QC to logistics/distribution and thus accompany the system project from planning to market launch.
• Common project management methods forms the basis of your working methods. Keep a constant eye on project risks, ensure transparent assessment, communication and develop solutions to minimize risks.
• Overview of GMP conformity and compliance with applicable regulatory and legal requirements.
• professional management of an interdisciplinary project team Ensuring the timely creation of project plans, conducting regular project meetings, Setting and monitoring of project milestones Ensuring the creation of project reports and implementation of project-related internal and external reporting Regular communication with the customer, participation in customer visits, customer support on site, Clarification of customer inquiries or customer change requests
• Project planning and controlling
• Scheduling and scheduling
• Cost and resource planning
• Progress monitoring
• Requirements management
• Ensuring continuous product and process Process quality of our international suppliers - based on specifications and standards as well as customer-specific requirements
• Qualification of new suppliers (system, process release) at the suppliers' premises
• Planning and fulfillment of relevant topics of advance quality planning at the supplier as well as monitoring of milestones in coordination with the project team in purchasing
• Coordination with suppliers regarding sampling contents
• Process development with suppliers including qualification and validation
• Supplier monitoring / supplier evaluation in coordination with the purchasing department
Catalent Pharma SolutionsInterim Technischer Projektmanager
Feb. 2022 - Jun. 2022Schorndorf, Baden-Württemberg, Deutschland · HybridInterface role between Research and Development, the relevant stakeholders of the Business Area as well as all relevant interfaces within Global Operations.
• Within Global Operations responsible for the coordination of all functions from external partners, purchasing, production, QC to logistics/distribution and thus accompany the system project from planning to market launch.
• Take over the technical leadership of the Operations project team and is responsible for budget (CAPEX, OPEX), result, time, supply chain, production (filling) and quality targets.
• Common project management methods forms the basis of your working methods. Keep a constant eye on project risks, ensure transparent assessment, communication and develop solutions to minimize risks.
• Overview of GMP conformity and compliance with applicable regulatory and legal requirements.
RocheInterim Project Lead Global Operations
May. 2021 - Jan. 2022Mannheim, Baden-Württemberg, Deutschland · Hybrid• Interface role between Research and Development, the relevant stakeholders of the Business Area as well as all relevant interfaces within Global Operations.
• Within Global Operations responsible for the coordination of all functions from external partners, purchasing, production, QC to logistics/distribution and thus accompany the system project from planning to market launch.
• Take over the technical leadership of the Operations project team and is responsible for budget (CAPEX, OPEX), result, time, supply chain, production (filling) and quality targets.
• Common project management methods forms the basis of your working methods. Keep a constant eye on project risks, ensure transparent assessment, communication and develop solutions to minimize risks.
• Overview of GMP conformity and compliance with applicable regulatory and legal requirements.
IDT BiologikaInterim Programm-Manager
Oct. 2020 - Apr. 2021Dessau-Roßlau, Sachsen-Anhalt, Deutschland · Hybrid- Customer support for project-related inquiries
- Professional management and coordination of an interdisciplinary project team
- Control of the timely and cost-effective implementation of the agreed milestones of a major project
- Creation of work packages and cost calculations in close coordination with the relevant internal departments
- Cost control for the execution contents of the contracts of a project, including ensuring accounting
- Development of concepts for the optimization and standardization of processe
- Pharmakovigilanz
Haselmeier GroupInterim Programm-Manager
Aug. 2020 - Oct. 2020Stuttgart, Baden-Württemberg, Deutschland · On-site• Creation of a project plan;
• Coordination between customer (USA), external development partner (USA) and project team (DE) based on the project plan;
• Supervise various sub-projects (assembly line setup, pharmaceutical production, • coordination of 15 new tools for plastic parts);
• Evaluation of the injection moulding production;
• Consulting for the implementation of appropriate safety measures within the project;
• Reporting to the department heads responsible for the subproject and the overall project;
• Documentation of project status and progress.
• Planning, control and management of projects for medical devices and connectivity • Management of several new and further development projects in cooperation with international customers and suppliers • Accompaniment of project implementations in our production facilities and at suppliers • Support of the key account manager in the inquiry and offer phase and after placing the order • Close cooperation with the sales department to support and advise existing customers • Creation and continuous updating of resource and budget planning • Ensuring project administration and project documentation in accordance with regulations • Illustration of the interface between development department and customer
BaldaInterim Senior Project Manager Business Development
May. 2020 - Jul. 2020Bad Oeynhausen, Nordrhein-Westfalen, Deutschland · HybridProject 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
SanofiInterim Senior Technology Project Manager
Jul. 2019 - Apr. 2020Frankfurt/Rhein-Main · On-site• 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
NovartisInterim Device &; Packaging Transfer Team Lead
Oct. 2018 - Jun. 2019Basel, Basel-Stadt, Schweiz · HybridProfessional 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 BTDM
• Maximizes project value.
• Provides technical expertise from commercial point of view, during device development stages and process commercilization
• Manages technical launch activities (process, technology, capacity, resources) for assembly and packaging at involved sites.
• Assures that all activities are performed acc. To current processes and standards (GMP, HSE, • 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 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.
Financial responsibility
(Budget, Cost, Sales, etc.)
The Janssen Pharmaceutical Companies of Johnson & JohnsonInterim Technischer Manager
Apr. 2018 - Oct. 2018Bern, Schweiz · On-siteThe 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 global marketplace. 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 • 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) • Hands-on mentality, intrinsically motivated, excellent coordinator • Organize and direct multi-disciplinary teams effectively towards the project goal
• 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 accurately interpreted and implemented
Competencies • IQ/OQ/PQ/PV
• Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
• Strong knowledge of GMP, GAMP, SOPs and quality systems. • Acc. to defined project KPI’s
Allergopharma GmbH & Co. KGInterim Projektmanager
Nov. 2017 - Mar. 2018Reinbek, Schleswig-Holstein, Deutschland · On-site 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/EC MDD 93/42/EEC DIN ISO 13485:2016
ISO 10993 “Biological evaluation of medical devices”
Biedermann MotechInterim Business Process Manager
Aug. 2017 - Oct. 2017Villingen-Schwenningen, Baden-Württemberg, Deutschland · On-siteBusiness 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 Titan
Validation of design processes
Sterilization of instruments and implants from sub supplier Früh
Paul Hartmann GmbH & Co. KGInterim Project Manager R&D
Mar. 2017 - Aug. 2017Heidenheim, Baden-Württemberg, Deutschland · On-siteManagement/coordination of development projects and product change projects in the area of Incontinence management
Responsibility for material product specification and their maintenance
Production and maintenance of the technical documentation (Product Risk Management File, Design History File, Material and Product Specification etc.)
Qualification of suppliers and accompanying the audits
Selection 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 results
Support of the product registration processes (EU and Non-EU) by supply of the necessary data
Assessment of the customer complaints within the defined area of responsibility and if necessary initiating of measures
Patent assessments and observation of the market sphere ISO 13485 ISO 10993 “Biological evaluation of medical devices” CAPA Process ISO 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
DePuy Synthes CompaniesInterim Project Manager Manufacturing Process Information
Aug. 2015 - Feb. 2017Solothurn, Schweiz · On-siteTo work with Suppliers / Manufacturing Sites to document the process flow
Monitoring 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 achieved. Build positive relationships with customers and suppliers
To 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 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.
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
Validation of design processes
Sterilization of instruments and implants from sub supplier Früh
NORMED MEDICAL GROUPInterim Project Manager / Team Lead DHF
Oct. 2014 - Jul. 2015Tuttlingen, Baden-Württemberg, Deutschland · On-siteProject 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 documentation
Document management
Leading, developing, motivating and managing the work force
Manage CAPA/NCR activities, acting as a liaison between Quality Assurance and Manufacturing in the area of CAPA/NCR
Work with the FDA (21CFR Part820)
Experience with ISO 10007
Experience with ISO 14971
Experience with ISO 13485
ISO 10993 “Biological evaluation of medical devices” 510K
Creation of Project plans and Milestone supervision
carry out DHF remediation activities as per approved remediation plan
implants and screws of Titan
Validation of design processes
Sterilization of instruments and implants from sub supplier Früh
develop protocols and procedures
technical writing-reports and technical justification
develop understanding in functional / system testing of medical devices
GxP experience, and knowledge of supplier Quality management and Quality auditing.
Knowledge of GxP, ISO 13485and local quality regulatory requirements. Remediation for the FDA
Interface for RA
Interface for the QM
Design Control
Beckman Coulter Life SciencesInterim Project Manager / Sub Team Lead
Apr. 2013 - Sep. 2014München, Bayern, Deutschland · On-siteProject 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 efficiency
Technical documentation
Leading, developing, motivating and managing the work force.
Create, control, coordinate and manage an environment for effective and economic production of quality product.
Document management
Lead, direct and manage the communication between the departments
GxP 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 reports
Follow all company’s filed procedures and protocols
Cooperate with other line managers and share information across the Organization
Comprehend customer requirements and make appropriate recommendations/briefings
Working with purchasing staff to establish quality requirements from external suppliers
Interface for other Departments like EE, QA, Procurement, Software
Creation of Project plans and Milestone supervision
Coordination of construction, production, purchase, logistic.
Setting up and maintaining controls and documentation procedures
Drawing Inspection
Making suggestions for changes and improvements and how to implement them
Concept Inspection
Design Inspection
Validation of the design process
Document review
Technical documentation for the FDA
Change Management
Kaizen
EMV
FMEA
Risk Management (ISO 14971)
Look for new supplier
DBS Leadership
Requirement Management
Requirement Analysis
Experience with ISO 13485 Experience with DIN EN 60601 Design Control
worked with steel metal and aluminium
worked with cast iron
worked with cast aluminium
worked with sheet metal
BOMBARDIERInterim Project Leader and Quality Management
Jan. 2012 - Apr. 2013Berlin, Berlin, Deutschland · On-siteProject leader and Quality Management (contract)
Software Change Request
CAPA Specialist
Budget tracking
Lead, direct and manage the communication between the departments
Monitoring performance by gathering relevant data and statistical reports
Follow all company’s filed procedures and protocols
Cooperate with other line managers and share information across the Organization
Comprehend customer requirements and make appropriate recommendations/briefings
Planning, organizing and supervise the achievement of goals on different time scopes Manage the resources
Coordination of software development, testing, quality, logistic
Leading, developing, motivating and managing the work force
Making suggestions for changes and improvements and how to implement them
Engineering Budget Request
Creation of project plans and milestone supervision resource planning and supervision Technical documentation
Document management
V-Modell
Projectplanning und Controlling
Termin controlling
Budget planning
Progress controll
Change- / Konfiguration-Management
Risikomanagement
Multiproject management
Programm management
Quality management Tools (MS-Project) und MS-Office (Word, Excel, Powerpoint)
Life Projektmanagement
Document management
XTREME Technologies GmbHInterim Project Lead
Feb. 2011 - Nov. 2011Aachen, Nordrhein-Westfalen, Deutschland · On-siteProject leader and Quality Management (contract)
Implementation and Optimization of processes Implementation of Configuration- and Instancemanagement
Quality control of prototypes Supply management
Creation of Project plans and Milestone supervision Planning and performing of Power upgrades of different product lines
Coordination of construction, production, purchase, logistic
worked with steel metal and aluminium
worked with cast iron
worked with cast aluminium
worked with sheet metal
Self-employedInterim Chief Operating Officer
Jan. 2011 - Oct. 2023Frankfurt am Main, Hessen, Deutschland · On-site
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