Charlotte Borgensgaard Email and Phone Number
Charlotte Borgensgaard work email
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Charlotte Borgensgaard personal email
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I have 25 years of global experience heading quality and regulatory affairs in primary plastic packaging for pharmaceuticals and medical devices. During my career I have worked with plants in Europe, US, South America and Asia and have developed and implemented global standards for Quality Leadership, Quality Management and Regulatory Affairs. I have been working with small, medium and large organizations having different complexity and maturity, and know how important it is to understand where they are coming from, to support a good and realistic development process. My approach is business-oriented and holistic with focus on creating value for company, employees, products, customers and end-users. I combine extensive knowledge in quality and regulatory requirements in life science industry with my interest in the science of behavioral psychology. I enjoy working with people and teams helping them with leadership, quality management and improvements. My approach is to ensure that solutions supports the strategy while it is transmitted into practical and workable solutions in compliance with applicable requirements. My personality is open and friendly, and I have a high level of integrity and responsibility and put a lot of passion into my work. I strongly believe in an open and honest communication.For more details, please see my personal profile on https://borgensgaard-consulting.dk/cv-charlotte-borgensgaard/ You are also welcome to contact me: mobile +45 30 328 327email charlotte@borgensgaard-consulting.dk#qualitymanagement #leadership #humanbehavior #ISO13485 #ISO15378 #ISO9001 #medical device regulation #GMP
Borgensgaard Consulting
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Owner And Senior Management ConsultantBorgensgaard Consulting May 2019 - PresentCopenhagen Area, Capital Region, DenmarkI help companies, teams and professionals to improve quality performance and reduce human error by strengthen leadership and effective quality management in compliance with applicable requirements and based on the science of human nature and behavior. My services include:• Counselling & Coaching• Workshops, Seminars, Webinars• Project Management• Compliance and efficiency checks including auditing• Structure, optimization and simplification• Implementations• Interim management• Board work & Advisory boardYou can find more details on the topics that I cover in relation to Quality Leadership, Quality Management, Regulatory Compliance and Human Behavior on my homepage https://borgensgaard-consulting.dk
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Director Medical DeviceAlfanordic A/S Jun 2018 - Apr 2019Director for consultant team providing services to medical device companies in quality assurance and regulatory affairs. Senior consultant on Medical Device solving: - Regulatory evaluations and strategies for start-up companies and large organization new to medical device- Process and software validation - evaluation of compliance and proposal for new approach - Counselling on process validation and performed training - Risk management - Implementation of new approach and training- Quality management system for distributors of medical devices- Evaluation of production facility and quality management system and proposal for improvements -
Global Senior Director Quality & Regulatory Affairs, Plastic PackagingGerresheimer Sep 2014 - May 2018Copenhagen Area, Capital Region, DenmarkMy responsibility covered manufacturing plants / units in Denmark, Poland, Spain, India, US, Brazil, Argentina and a global regulatory affairs department. I was a member of the management team for the Plastic Packaging organization. and have been actively involved in acquisitions and integration of acquired plants. -
Chairman For Gerresheimer Quality CouncilGerresheimer Apr 2010 - Feb 2016On top of my daily job, I started-up and was holding the position as chairman for a group quality council for 6 years, representing more than 40 plants worldwide. Members of the Quality council is quality directors for all business units. Quality vision, strategy, quality culture and standardized KPI reporting was defined and rolled-out.
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Director Quality & Regulatory AffairsGerresheimer Plastic Packaging Aug 2012 - Sep 2014I am located in Denmark but am working globally. My responsibility covers manufacturing plants / units in Denmark, Poland, Spain, India, Brazil, Argentina and a global regulatory affairs department. I am a member of the management team for Plastic Packaging organization and have been actively involved in acquisitions and integration of acquired plants.
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Quality DirectorGerresheimer 2006 - Aug 2012Vaerloese, DenmarkI am located in Denmark but am working globally. My responsibility covers manufacturing plants / units in Denmark, Poland, Spain, Brazil, Argentina and a global regulatory affairs department. I am a member of the management team for the Plastic Packaging organization and have been actively involved in acquisitions and integration of acquired plants.
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Quality ManagerSuperfos Apr 2002 - Jan 2006Copenhagen Area, Capital Region, DenmarkQuality Manager in Superfos Pharma manufacturing primary plastic packaging for pharmaceuticals. Responsibility covered plants in Denmark and England and included QA, QC, Customers, Suppliers, Regulatory Affairs. -
Business Unit Manager / Product Unit ManagerScribona Danmark Aug 2000 - Mar 2002Copenhagen Area, Capital Region, DenmarkFull business responsibility for B2B sales of Compaq and Toshiba hardware to local market. The responsibility included sales, marketing, product management and logistics (purchase, warehousing). Close cooperation and negotiation with Compaq and Toshiba in Denmark. -
Quality ManagerPolystan Feb 1997 - Jul 2000Copenhagen Area, Capital Region, DenmarkQuality Manager for a medical device manufacture, producing products for heart-lung surgery: heart-lung machines, oxygenators, catheters, cannulaes, sensors. Responsibility included product registrations and a microbiological laboratory. Additionally I took care of some HR tasks.
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Pacs Product & Project ManagerPhilips Aug 1996 - Jan 1997Copenhagen Area, Capital Region, DenmarkPosition in Philips Medico A/S which was a Danish subsidiary of Philips Medical Systems. Responsible for sales and project management / implementation of PACS: Picture Archiving & Communication System. Took over the position after a change in management and re-organization. -
Quality, It, Marketing ManagerPhilips Medical Systems Mar 1993 - Aug 1996Copenhagen Area, DenmarkPosition in Philips Medico A/S which was a subsidiary of Philips Medical Systems. My responsibility covered the location in Denmark where I took care of Quality, IT and Marketing including all quality related issues around the quality management system, audits, customer satisfaction surveys, strategies, marketing plans, prospect planning, standardization of IT and optimization of use etc.
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Nordic Quality ManagerPhilips Mar 1992 - Mar 1993DenmarkNordic Quality Manager covering Denmark, Norway and Sweden. My position changed as the Nordic organization was dissolved. The local units was covering sales, installation and service of X-ray systems, MR, CT and ultrasound scanners. Main task was to get all unit ISO 9001 certified.
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It DeveloperPhilips Aug 1986 - Feb 1992Copenhagen Area, DenmarkDevelopment of manufacturing / logistic system for the local plants in Denmark. Tasks included development, programming, project management and user support.
Charlotte Borgensgaard Skills
Charlotte Borgensgaard Education Details
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Logistic -
Købmandsskolen, EdbskolenIt -
Borupgaard AmtsgymnasiumStudent
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EgebjergskolenAfgangseksamen
Frequently Asked Questions about Charlotte Borgensgaard
What company does Charlotte Borgensgaard work for?
Charlotte Borgensgaard works for Borgensgaard Consulting
What is Charlotte Borgensgaard's role at the current company?
Charlotte Borgensgaard's current role is Senior Management Consultant helping life science industry | Quality Leadership | Quality Management | Medical Device Regulation.
What is Charlotte Borgensgaard's email address?
Charlotte Borgensgaard's email address is c.****@****mer.com
What schools did Charlotte Borgensgaard attend?
Charlotte Borgensgaard attended Copenhagen Business School, Købmandsskolen, Edbskolen, Borupgaard Amtsgymnasium, Egebjergskolen.
What skills is Charlotte Borgensgaard known for?
Charlotte Borgensgaard has skills like Quality System, Quality Management, Iso, Iso 13485, Continuous Improvement, Plastics, Gmp, Process Improvement, Medical Devices, Change Management, Packaging, Kaizen.
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