Vice President Of QA and RA

• Oct 2021 - Present

Principal QA Adviser - owner One QA

• Jul 2021 - Present

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. 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.

QA compliance and processes Director

• Jul 2020 - Jun 2021

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 Quality Management reviewo External (FDA and NB Audits) and internal Audit programs including supplier audits and Customer Auditso IT system validationBusiness representative on global IT projects within own areao QA Track-lead on SAP implementation in manufacturingo QA track lead on Legal entity ChangeChange ManagementMajor achievements:• 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 Show less

QA Operation and Vigilance Manager

• Jun 2019 - Jul 2020

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 organization and restructure the current organizationo Establishment of a new global process for vigilance managemento Setting the NCR team and process up for success and driving down the backlog of open casesBusiness representative on global IT projects within own areao New Complaint systemo New Vigilance systemHandle Change Management in own team and support other decisionsMajor achievements:• 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 Show less

Complaint & Vigilance Manager

• Aug 2016 - Jun 2019

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 of a new global process for vigilance management including IT toolsBuilding up the right organizationMajor achievements:• 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 Show less

Senior Consultant QA/RA

• Nov 2012 - Jul 2016

Key responsibilities: Sales responsible Building up the QA Organization and daily management of the QA/RA team Provide consultancy services to main customers Maintain and secure continued certification of QMS (ISO 13485) Provided support from Idea to market entry for Medical Devices and IVD Ensure the Company profile is exposed through networking, conferences and B2B marketing Project management Major achievements: • 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 customer Main business partners: • Coloplast, Haldor Topsoe, Ferring Pharmaceuticals, Guldmann, Lina medical, MEQU, Motility Count Show less

Senior consultant

• Jan 2012 - Oct 2012

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 internally Major achievements: • Cooperation agreements with 2 Devices development companies • Redesign and Launch of new website • Developed new company profile • Expanded existing jobs with 2 main customers. Main business partners: • SPX, Radiometer, Genzyme, Coloplast, SSI Schäfer, Novo Nordisk, Haldor Topsoe Show less

Director Quality Process Development

• Mar 2010 - Aug 2011

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• Ensure Training offers in Coloplast Academy for the QEHS area• Business partner between Corporate Q&E and Global MarketingMajor Achievements:• Global implementation of standardized QEHS tool in 34 countries.• Removed all paper based documentation for Vigilance handling• Developed and implemented Global tool for training administration• Redesigned the Change Control process – increased “right first time” from 55 to 88%• Established KPI for monitoring of cost of quality organisation globally Show less

Director QEHS Concepts

• Jun 2008 - Mar 2010

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.• Ensure Training offers for all relevant employees within the QEHS area• Key focus on Risk Management, Validation, Calibration and MaintenanceMajor Achievements:• Ensured standard training in PRINCE 2 for IT project managers in my team• Established a total overview of IT applications supporting quality and regulatory affairs• Centralized and standardized all IT support for QEHS IT applications• Established guidelines for Global Process ownership• Implemented the first standalone monitoring system for Clean rooms Show less

Corporate Quality Development Manager

• Jan 2004 - Jun 2008

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• LEAN SpecialistMajor Achievements:• Redesigned and implemented an entire new setup around product Risk management and linked it directly to Postmarked surveillance and process validation.• Implemented the document tool “Documentum” Globally• Worked out the overall procedure for transfer of production. (Coloplast has transferred more that 300 processes from Denmark to low-cost countries)• Chairman for quality workgroup – related to “Globalization of manufacturing in Coloplast”• Developed first prototype of E-learning module for statistical training• Standardized all calibration activities with a few suppliers.• Executed 16 global LEAN events Show less

Validation Coordinator

• Apr 2002 - Jan 2004

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:• Ensured full site validation prior to 1/1-2004• Developed Validation techniques for injection moulding machines – the technique were adopted by the manufacture due to the high precision• Trained all relevant personnel in validation. Show less

Quality Engineer

• Feb 2001 - Apr 2002

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• Purchased and installed the first 3D measuring equipment• Established database for keeping track of measuring assignment from R&D and Technical Department Show less

Project Manager

• Oct 1999 - Feb 2001

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