Melanie Vogel
Head GMP Quality Management and CMC at Santhera Pharmaceuticals- Claim this Profile
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Deutsch Native or bilingual proficiency
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Englisch Full professional proficiency
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Italienisch Elementary proficiency
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Spanisch Elementary proficiency
Topline Score
Bio
Credentials
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Qualified Person
CONCEPT HEIDELBERG GmbHMar, 2021- Nov, 2024 -
GMP Lead Auditor
CONCEPT HEIDELBERG GmbHJan, 2014- Nov, 2024
Experience
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Santhera Pharmaceuticals
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Switzerland
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Head GMP Quality Management and CMC
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Apr 2021 - Present
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Responsible Person (FvP) Switzerland and Liechtenstein
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Apr 2021 - Present
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Euro-FH Europäische Fernhochschule Hamburg
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Higher Education
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1 - 100 Employee
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Process Management Consulting / Social Media and e-Marketing Management
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May 2020 - Apr 2021
Process Management Consulting: - Consulting and Business Development - Innovation Management - Mergers and Aquisitions - Business Engineering (Process Management, -modeling, -analysis and -optimization) Social Media & e-Marketing Management - Onlinemarketing - Social Media Management (planning, evaluation, community management, crowdsourcing) - e-commerce (onlineshop, payment, planning, strategy, marketing & trends) - cyberlaw Process Management Consulting: - Consulting and Business Development - Innovation Management - Mergers and Aquisitions - Business Engineering (Process Management, -modeling, -analysis and -optimization) Social Media & e-Marketing Management - Onlinemarketing - Social Media Management (planning, evaluation, community management, crowdsourcing) - e-commerce (onlineshop, payment, planning, strategy, marketing & trends) - cyberlaw
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CSL Vifor
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Head of Congress Management
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Jul 2018 - Apr 2020
- Development and execution of the Vifor Pharma Congress Strategy to ensure Vifor Pharma has top presence at priority congresses and effective promotion - Owning the end-to-end delivery and execution of complex large scale congresses along with other meeting and event activities utilizing standard process and procedures to achieve the overall Marketing and Medical goals - Driving cross-functional congress approach by leading a coordinated effort for each international major congress - Ensuring the organizational understanding and awareness around congress work, data, and presence throughout the year - Managing significant agency and congress organization relationships and ensuring partners have what they need to deliver successful services to maximize value for given budget - Owning KPI congress dashboard and reporting data on a regular basis - Identifying new opportunities and technologies to extend the Vifor messaging reach to HCPs that cannot attend F2F congresses or be impacted by the sales force - Driving compliance with all legal and regulatory rules & guidelines - Provide guidance and resolution on escalation issues and mitigate risks; providing guidance to Congress Manager on project, hotel and travel escalation issues - Leverage emerging technologies to ensure effective booth execution and impact with attendees - leading cross functional Projects with internal/external stakeholders to optimize the internal processes (new digital solutions for congress communication with HCPs, event app development, implementation of congress logistic software for the Vifor Pharma Group)
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Vifor Fresenius Medical Care Renal Pharma
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Switzerland
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Pharmaceutical Manufacturing
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1 - 100 Employee
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International Product Manager i.v. Iron
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Aug 2016 - Jun 2018
CFP Lead (Cross Functional Program) to ensure a clear product positioning for Ferinject ® and Venofer ® in Nephrology in EU • support development of the GBP (Global Brand Plan), execute projects according to the plan including budgeting • support and track country implementation of the GBP in countries in close collaboration with the Vifor Pharma country organizations • ensure alignment between HQ and EU affiliates to optimally execute strategy, product positioning, segmentation and disease awareness campaigns • elaborate and implement key differentiation messaging to strengthen the brand in all key therapeutic areas • development of global promotional materials and tools for HCPs, Nurses, Pharmacist and Patients • support and track the execution of the customer and patient segmentation process in the countries • Brand Lead for Congress strategy, plan and execute international congresses • analyze and extract key insights from market research and translate into materials/activities
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CSL Vifor
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Manager Corporate Quality Unit
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Jan 2015 - Jul 2016
• Development, implementation and harmonization of global Quality Management processes and systems (including Training Management, Supplier/ Third Party Management, QMS, CAPA and Deviation process, Computer System Validation (CSV), Auditing, Document Management)• Lead and support cross-functional projects and activities to improve and maintain the overall GxP compliance level in Vifor Pharma (including manufacturing sites, global functions and affiliates)• Development and execution of the global Quality Risk Management process (QRM acc. ICH Q9) including training• Support the development and track the implementation of the local Quality Risk Management process • Global Business Process Owner of the LIMS system (LABS/Q)• Global Business Process Owner of the Trackwise system (Supplier Management/Auditing)• Global Business Process Owner for Operational Excellence program in all Quality Control Units of the Vifor Pharma Group• Qualified and certified GMP and GDP Lead Auditor• Lead and support Computer System Validation (CSV) projects acc. to GAMP and CFR Part 11 • Teamlead (direct reports)
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Deputy Head Quality Control
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Apr 2013 - Dec 2014
• Team leader (direct personnel management of 5 employees, indirect 35 employees)• Release of raw and packaging materials and APIs (Active Pharmaceutical ingrediants)• Implementation of Lean Management and Operational Excellence in the QC department (Analyzing present QC processes, implementation of innovations to save time, costs and increase quality (Continuous Quality Improvement), measurement of success with a Quality KPI Dashboard)• QC organisation (budgeting, personnel planning)• Project Leader for QC related projects and E2E Supply Team• local Business Process Owner for the Training and Supplier Management, CAPA and Deviation workflow• Writing and review of QC related procedures and specifications and Train them within the organization• Auditing of suppliers and manufacturers
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Group Leader Quality Control (raw and packaging materials)
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Dec 2009 - Mar 2013
• Direct Personnel management of 4 employees• Responsible for release of raw and packaging materials for the API production• Deputy for Group Leader API / FP Release• Business Process Owner: Continuous Quality Improvement• Project Leader for QC/ Supply Chain Management projects related to raw and packaging materials• Responsible for Sampling Process of raw and packaging materials and API• Writing and reviewing QC documents (GMP), e.g. procedures, specifications• Auditing of suppliers and manufacturers
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Boehringer Ingelheim
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Germany
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Pharmaceutical Manufacturing
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700 & Above Employee
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Graduate Research Associate
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Mar 2005 - Nov 2009
multistage synthesis of biological active substances responsible for chromatographical equipment (Agilent, Waters and Gilson for normal and reversed phase in the analytical way and preparative for purification) testing and further development of new chemical equipment with other companies (Teledyne ISCO) multistage synthesis of biological active substances responsible for chromatographical equipment (Agilent, Waters and Gilson for normal and reversed phase in the analytical way and preparative for purification) testing and further development of new chemical equipment with other companies (Teledyne ISCO)
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Ciba
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Chemical Manufacturing
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500 - 600 Employee
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Student Internship
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Aug 2004 - Oct 2004
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Education
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Europäische Fernhochschule Hamburg
Process Management Consulting -
Europäische Fernhochschule Hamburg
Social Media & e-Marketing Management -
Europäische Fernhochschule Hamburg
Master of Business Administration (MBA), Internationales Management -
Naturwisschenschaftlich- Technische Akademie, Prof. Dr. Grübler gGmbH, Isny
Diplom-Ingenieurin (Dipl.Ing.), Allgemeine Chemie