Head of Quality Assurance

Location:  Stockholm, Sweden

The role in general

The Head of QA will lead and build and support the quality system at OxThera. The role holder will also work hands-on with quality matters connected to the out-sourcing of manufacturing projects including reviewing quality assurance and quality control testing data to CMOs. He or she will also be responsible for and involved in audits and inspections of CROs and CMOs.

Key Responsibility Areas

  • Responsible for QA work in general at OxThera
  • Hands-on work with defining, setting up, implementing and maintaining  the Oxthera quality system
  • Provide QA review and approval as appropriate of internal and external (from CMO) quality documents
  • Ensure risk based audit strategy and that yearly audit programs are approved and executed
  • Review and approve audit responses and CAPAs
  • Coordinate or perform audits and ensure timely follow-up, escalate as needed
  • Train internal stakeholders in the quality system and regulatory requirements
  • Ensure that QA functions and procedures at CMOs are documented and followed for the drug supply
  • Sponsor release of Drug Product for the market


  • Bachelor´s degree or higher in Life Sciences


  • Minimum 10 years working experience in the pharmaceutical industry and minimum 5 years experience working with quality assurance and audits
  • Sound knowledge of regulatory requirements within GMP/GDP and experience of inspections
  • Experienced in managing Risk Assessments and yearly Audit Programs, managing Deviations and CAPAs and auditing Contract Manufacturing Organisations
  • Experienced in managing Deviations, CAPAs and Change Control

Skills and abilities

  • Excellent communication skills in Swedish and English and ability to communicate strategic direction of QA in relation to the regulatory environment
  • To be able to work in a complex environment and collaborate with many stake holders

More information and application

Please call Knut Natt och Dag on +46 722 166 800 if you have any questions. Apply by e-mailing your CV and a personal letter to as soon as possible. We are working continuously with this recruitment project. Write “Head of Quality Assurance” in the subject field.