Director QA - OxThera AB

Do you want to devote yourself taking part in the work developing new drugs for patients with severe kidney disease with no cure today? You will work with development of a treatment for a disease that particularly strikes children.

Your work is to build and support the quality systems at OxThera as well as work hands-on with quality matters connected to the outsourcing of manufacturing projects including quality assurance and quality control testing to CMOs. You will also be responsible for the audit program and involved in inspections of CROs and CMOs.

Key Responsibilities

  • Responsible for QA at OxThera
  • Hands-on work with defining, setting up, implementing and maintaining the OxThera quality system
  • Drive quality-related issues, both internally and externally
  • Handle and assess internal and external (from CMO) quality documents as deviations and change control documentation
  • Ensure risk based audit strategy and that yearly audit programs are approved and executed
  • Coordinate or perform audits and ensure timely follow-up, escalate as needed
  • Train internal stakeholders in the quality system and GMP requirements
  • Represent OxThera QA in the different manufacturing teams with CMOs. Ensure that QA functions and procedures at CMOs are documented and followed for the entire manufacturing chain
  • Take part in tech transfer project
  • Act as expert and advise on GMP / GDP in quality issues
  • Participate in the preparation of quality agreements
  • Assist in compliant investigations

Desired Education, Skills and Experience

  • Strong (minimum 10 years) working experience in the pharmaceutical industry and minimum 5 years experience working with quality assurance and audits. 
  • Strong knowledge of  EU and FDA GMP/GDP requirements and experience from inspections. 
  • Experience in managing Risks Assessments and yearly Audit Programs and auditing Contract Manufacturing Organisations.
  • Experience in managing Deviations, CAPAs and Change Control.
  • 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.
  • Batchelor’s degree or higher in Life Sciences
  • Qualified Person competence according to LVFS 2004:7 desirable

Reporting

You will report to the COO of OxThera. 

Application and more information

Please call Knut Natt och Dag on +46 722 16 68 00 if you have any questions. You are welcome with your application by e-mailing your CV and personal letter to knut.nattochdag@aktivia.se as soon as possible. It is not enough to only send a link with your LinkedIn-profile. We are working continuously with this recruitment project and would like to receive your application as soon as possible. Write ”Director QA” in the subject field.

OxThera is cooperating with Aktivia Science Work in this recruitment. Aktivia Science Work is a recruiting and consulting company within Life Sciences specialized in positions within the pharmaceutical industry – from early discovery through pharmaceutical development and clinical development to the market place. We are members of SwedenBIO. You can read more about us at or website – www.aktivia.se

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