Experience

Oncopeptides AB (publ)

• Sweden
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Acting Global Head of QA, GxP

  • Jun 2022 - Present

• Global QA Director GCP/PV

  • Jun 2020 - May 2022



Region Stockholm

• Sweden
• Government Administration
• 700 & Above Employee

• Quality Manager & Process leader, Regional Biobank Centre-Stockholm & Stockholm Medical Biobank

  • Nov 2016 - May 2020



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Compliance Manager

  • Feb 2012 - Mar 2017

  Support the company globally by ensuring that the procurement risks are identified through an annual assessment cycle and appropriately managed through the assurance and improvement of functional processes and policies. This includes appropriate implementation activities, establishing support structures, advising management, giving general assistance in relation to assurance program / risk questions / issues, and contribution to strategy and policy decisions at a functional level.Designed, implemented and maintained an effective assurance program for the procurement functionDesigned, implemented, educated and maintained the third party risk assessment process for all suppliersConducted assurance activities, support for process effectiveness, investigations, assurance reporting etc.Designed, implemented and maintained the risk framework and risk register for the procurement functionConducted monitoring and auditing of procurements adherence to company Code of Conduct and global policies Conducted investigations reported through the company’s whistle-blower systemManager for the relationship with third party audit providerDeveloped and implemented global policies for procurement functionIdentification of process gaps, monitored improvement activitiesConducted risk and trend analysis of supplier data Provided risk advice to procurement directorsResponsible for Procurements Dow Jones Sustainability Index submission Show less

• Global Lead Advisor, Compliance Advice & Assurance

  • Aug 2011 - Feb 2012

  Provided compliance advice, developed audit programs and conducted audits (studies, projects, systems and specific compliance areas) globally, communicated audit findings and improvement recommendations both internally and externally including vendors and other providers of clinical services in line with the global Quality &Compliance strategic direction and individual compliance area/region strategic decisionsResponsible for risk identification and monitoring of improvement activitiesActed as lead point of interface for delivery of Compliance Advice & Assurance activities for assigned clinical project teams and assigned business areasFacilitated and supported routine regulatory authority inspectionsParticipated in audits/initiatives with other compliance groups within the companyManaged audit requests for for-cause audits (e.g., investigator sites, Therapeutic Areas or region specific, systems, CROs, specific compliance areas) Show less

• Advisor, Compliance Advice & Assurance

  • Aug 2006 - Aug 2011

  Provided compliance advice, developed audit programs and conducted audits (studies, projects, systems and specific compliance areas) globally, communicated audit findings and improvement recommendations both internally and externally including vendors and other providers of clinical services in line with the global Quality &Compliance strategic direction and individual compliance area/region strategic decisionsResponsible for risk identification and monitoring of improvement activitiesActed as lead point of interface for delivery of Compliance Advice & Assurance activities for assigned clinical project teams and assigned business areasFacilitated and supported routine regulatory authority inspectionsParticipated in audits/initiatives with other compliance groups within the companyManaged audit requests for for-cause audits (e.g., investigator sites, Therapeutic Areas or region specific, systems, CROs, specific compliance areas) Show less

• Senior CRA/Monitor

  • Dec 1998 - Sep 2006

• Nurse/Administrator

  • Aug 1996 - Dec 1998



Karolinska University Hospital

• Sweden
• Hospitals and Health Care
• 700 & Above Employee

• Nurse

  • Nov 1986 - Aug 1996



Region Stockholm

• Sweden
• Government Administration
• 700 & Above Employee

• Nurse

  • May 1986 - Nov 1986



Karolinska University Hospital

• Sweden
• Hospitals and Health Care
• 700 & Above Employee

• Nurse

  • Jan 1981 - Jun 1986