Charlotte Borgensgaard Email & Phone Number

Copenhagen Area, Capital Region, Denmark

I 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

Director 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

Copenhagen Area, Capital Region, Denmark

My 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.

On 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.

I 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.

Vaerloese, Denmark

I 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.

Copenhagen Area, Capital Region, Denmark

Quality 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.

Copenhagen Area, Capital Region, Denmark

Full 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.

Copenhagen Area, Capital Region, Denmark

Quality 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.

Copenhagen Area, Capital Region, Denmark

Position 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.

Copenhagen Area, Denmark

Position 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.

Denmark

Nordic 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.

Copenhagen Area, Denmark

Development of manufacturing / logistic system for the local plants in Denmark. Tasks included development, programming, project management and user support.

Hd, Logistic

Edb-Assistent, It

Student

Afgangseksamen