Frank Winther-Hinge Email & Phone Number

Copenhagen, DK

Danmark

EventyrJul er en non-profit forening drevet af frivillige. Med børnene i centrum holder vi hvert år i København og Aarhus juleaften for socialt udsatte børn og forældre – med julemad, julepynt, juletræ og julegaver til alle. Vores mission er at give socialt udsatte børn og deres forældre en eventyrlig juleaften.For julen er hjerternes fest, men desværre.

Glostrup, Hovedstaden, Danmark

• Responsible of:
• Daily business with partners (Sales, People Management)
• Business Support (Salary, Accounting, Finance)
• Teaches in risk assessment (FMEA / FMECA), and GMP related topics

Vordingborg Area, Denmark

Provides leadership to the Board of Directors, who sets policy and to whom the Chief Executive is accountable.

Allerød, Hovedstaden, Danmark

• Overall business responsible for the pharma consulting devision (no. of employees: +100 / turnover: +100mdkk). Including department of:
• Pharma Academy
• IT & Automation
• Quality Assurance
• Validation & Compliance
• Production Support

Sjælland, Danmark

Overall business responsible for the devision of the former AlfaNordic, AlfaNordic US and AlfaNordic Academy (no. of employees: +70 / turnover: +85mdkk).Teaches in risk assessment (FMEA / FMECA), and GMP related topics

Hvidovre, Hovedstaden, Danmark

• AlfaNordic Academy works with development and investment in the market for training and education for the pharmaceutical and biotechnology industry. (no. of employees: +15 / turnover: +15mdkk)AlfaNordic Academy will.
• Management
• Business Development within education
• Strategy Management
• Project Management
• Sales Management

Herlev

• Initiator and "inventor" of Pharma Academy
• Facilitator for an international Quality Risk Management (QRM) project of an international pharma client (Novo Nordisk, Leo Pharma, Bavarian Nordic and others). The objective of this QRM project was to address known.
• Senior Project Manager for a Quality Risk Management (QRM) project for an international Biotech client. The QRM was a systematic process for the assessment (identification, analysis and evaluation) of risks to the.
• Senior Project Manager within a global SAP implementation for an international pharma client. Focus area (responsibility) was to identify, evaluate and manage the update of more then 1.700 documents (SOP, WI, Enc.).

Denmark

• Area of responsibility:
• Facilitator for several international Quality Risk Management (QRM) projects for Novo Nordisk, Leo Pharma and Bavarian Nordic

Greve, Denmark

Investment consulting

Beijing City, China

• Area of responsibility:
• Business development:Establishment of an independent subsidiary of RH Holding A / S in Beijing - China, with a focus on architectural business for Danish pharma customers in China (including Novo Nordisk, H. Lundbeck &.

Copenhagen Area, Denmark

• RH ARKITEKTER specializes in architectural consulting for the pharmaceutical industry, health care and research and educational institution. Top three clients are Novo Nordisk, H. Lundbeck and Leo Pharma. The company.
• Project Governance and management representative for key projects (>5mdkk)
• Finance and accounting of RH Holding ApS (incl. subsidiaries)
• Chief of staff (45 employees) – overall HR responsible
• Contracting and negotiating of all contracts, including key projects, suppliers and design/patent administration

India / Russia

NNE Pharmaplan is one of the world’s leading consulting and engineering company in the complex field of pharma and biotech. NNE Pharmaplan employs 1,700 people at more than 30 locations around the world.Management consultant and coach for the General Manager of the Russian (Moscow) and Indian (New Delhi) subsidiary.

Frankfurt Am Main-area, Germany

• Area of responsibility:
• Finance & Business Support (Quality Management, IT, HR, PM and Purchasing)
• Act as supervisor to the new appointed general manager of NP Germany
• Management link between NNE Pharmaplan GmbH covering subsidiaries in India, Malaysia, Switzerland, Russia and the Czech Republic.

Denmark / Germany

• Area of responsibility:
• Co-led the acquisition and integration of the German based engineering company Pharmaplan GmbH (320 employees in 8 countries). The integration involved the change from local to global Quality Management System, IT.
• Project Manager of strategic projects (e.g. internal cost/benefit program to lean the administrations costs)

Denmark

• Area of responsibility:
• Health, Safety & Environment Consultancy department (19 employees)
• Global alignment of ISO 14001 and OHSAS 18001
• Financial advisor to VP, responsible for P/L budgeting of 7 departments

Copenhagen Area, Denmark

• Area of responsibility:
• Project Manager for internal strategic projects (>5 M DKK)
• Development and launch of strategic tools for budgeting, controlling and manning.
• Co-led the start up the NNE’s subsidiary in US
• Responsible for the development of presentation material to the NNE A/S – General Management team / Board of Directors.
• Project Manager of several GxP Projects (<100 M DKK)

Gmp Update, Gmp, Gennemført

• EU GMP Annex 1 – Draft 2 - Status • FDA Enforcement and Compliance Trends • ICH Q12 -Technical and Regulatory Considerations for.

Gmp Update, Gmp, Gennemført

• Geneal EU GMP Updates • MRA EMA/FDA • MHRA GMP observation • Data integrity observations from DKMA • Covid - 19 new guidance •.

Gmp - Update

EU-GMP - Part I - Implemented changes EU-GMP - Part I - Future changes EU-GMP - Part III - Status EU-GMP - Appendix - Implemented changes.

Gmp - Brush Up - Risikovurdering (Ich Q9)

Lovgrundlag - et kort brush up - herunder DK, EU, FDA samt kvalitet i farmaceutisk industri, Q8, Q9 og Q10 ICH Q8 - Pharmaceutical.

Executive Mba, Master Of Business Administration, A

Activities and Societies: General Management

Mba Course, Competition And Strategy, B+

Competition & Strategy module by Professor Paul Tiffany from the Haas School of Business at the University of California, Berkeley, USA

Pld, General Management

Activities and Societies: Program for Leadership Development

Arbejdsret Og Assertiv Kommunikation

Cba, Certificate Of Business Administration, B+

General Management

Mba Course, Leadership & Organizational Behavior And Operations Management, B+

Leadership & Organizational Behavior and Operations Management module by Professor Joan Magretta from the Harvard Business School, Boston.

Coaching/Leadership

Eba, General Management

Activities and Societies: Diploma in Engineering Business Administration (EBA)

Gmp

Bsc., Electrical Engineering, B+

Electrician, Electrical And Electronics Engineering, A

Education record

Dansk Sommelier Uddannelse, Vin