Asger Dahlgaard Email & Phone Number

Copenhagen Metropolitan Area

København, Hovedstaden, Danmark

Providing strategic QA advice to your business and supporting your business finding the right quality level.Support business develop their QA organisations, culture and processes.20 + years in the regulated industry ensures that your business gets the right support you need.

Glostrup, Hovedstaden, Danmark

• Strategic management of QA organization, a key player in daily operation.Management of a team of +45 members including three direct managers and one manager more.Provide expertise and services to internal stakeholderso.
• Ensuring QA business continuity in the organization including transfer and restructure
• Continued transfer of Complaint and Vigilance to new Central Unit in US
• Maintain high team morale during time with high workload
• Delivered on all key objectives

Copenhagen Area, Capital Region, Denmark

• Strategic management of QA organization, a key player in daily operation.Management of a team of +35 members and three direct managers Business partner to Production, Marketing, Service, Procuremento Setting new.
• QA track lead on SAP and preparation of new legal structure
• Transfer of Complaint and Vigilance to new Central Unit in the US
• Transfer of both processes and skills, the existing team laid off or relocated
• Designed new organization and onboarded existing employees into a new organization
• Kept current team motivated in the process

Glostrup

• Key responsibilities:Strategic management of complaint, Vigilance and NCRManagement of a team of 26 members and two managers Establishment of a new global process for complaint handling including IT toolsEstablishment.
• Designed new setup for team and improved productivity by 4 time for complaint handling
• Designed and supported implementation of new process for Vigilance increasing speed and through put.
• Brought the business back in compliance from many Audit observation to zero in own area
• Managed major IT implementation that challenged the workload and processes in the department
• Supported implementation of new IVD-R for Complaint, Vigilance, NCR and Post Market Surveillance

Hilleroed

• Key responsibilities:Sales responsibleBuilding up the QA Organization and daily management of the QA/RA teamProvide consultancy services to main customersMaintain and secure continued certification of QMS (ISO.
• Grow QA/RA business from 1 to 4 people in 1,5 year
• Designed and supported the implementation of Integrated Quality management system
• Ensured market entry for 2 start-up companies.
• Project responsible for all major projects
• Supported global implementation of new QMS IT platform for 1 global customerMain business partners:

Holbaek, Denmark

• Consulting and project management with in Pharma, Biotech and medical devices industry. Key responsibilities:
• Expand the Medical Devices areas through sales activities
• Provide consultancy services to main customers
• Ensure the Company profile is exposed in Public media (website, ISPE, Conferences, b2b marketing)
• Provide support and sparring to colleagues internallyMajor achievements:
• Cooperation agreements with 2 Devices development companies

Humlebaek

• Key responsibilities:
• People management
• Overall responsible for development of quality related processes globally
• Overall responsible for ensuring all IT tools for the QEHS area are coherent and aligned
• Overall responsible for ensuring compliance and direction setting, between quality management system and regulatory requirements.
• Overall responsible for Postmarked surveillance including Vigilance

Humlebaek, Denmark

• Key responsibilities:
• People management
• Overall responsible for development of quality related processes globally
• Overall responsible for ensuring all IT tools for the QEHS area are coherent and aligned
• Overall responsible for ensuring compliance and direction setting, between quality management system and regulatory requirements.
• Overall responsible for IT project managers and IT support for QEHS systems.

Humlebaek, Denmark

• Key responsibilities:
• People management
• Overall responsible for Risk Management, Validation, Calibration and maintenance.
• Responsible for corporate procedures for above mentioned areas
• Chairman for Corporate Validation Competence Group
• Implementation of document management tool

Espergaerde, Denmark

• Key responsibilities:
• Member of local management team
• Ensure full site validation prior to 1/1-2004
• Responsible for ensuring all validation activities was executed
• Chairman for Corporate Test method Competence Group
• Member of Corporate Validation Competence GroupMajor Achievements:

Espergaerde, Denmark

• Key responsibilities:
• Responsible for the technological development of the QA department
• Responsible for validation of test methods
• System owner of qs-STAT (statistical program) on Corporate level
• Training of QA and production workers’Major Achievements:
• Established platform for electronic data capture in QA/QC lab

Aalsgaarde, Denmark

• Key responsibilities:
• Responsible for acquiring and qualifying injection moulds
• 3D Drawing of new components in corporation with R&D
• Maintenance of local proceduresMajor Achievements:
• Participated in the implementation and validation of drawing handling system “Smar Team”
• Purchased and installed the first Optical measuring equipment

Bachelor Of Science, Engineering

Activities and Societies: Student Council

Htx, Mechnical