Head of Quality Assurance - OxThera - Stockholm
OxThera develops biopharmaceuticals based on live microbiota and biomolecules. The company has long experience in the development of orally delivered biological drugs.
OxThera is a Stockholm-based privately-held biopharmaceutical company with products in late stage clinical development with focus on Primary and Secondary Hyperoxaluria. OxThera’s intellectual property includes worldwide patents for compositions and treatment of hyperoxaluria with bacteria (Oxabact®) and enzymes (Oxazyme®). Oxabact® holds Orphan Drug designations in Europe and in the US for treatment of Primary Hyperoxaluria. Clinical projects are in late stages and close to market applications with a very strong IP portfolio.
Hyperoxaluria is a condition diagnosed by increased levels of oxalate present in the urine. It can be caused by inherited (genetic) disorders, an intestinal disease or excess intake of oxalate-rich foods.
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 email@example.com as soon as possible. We are working continuously with this recruitment project. Write "Head of Quality Assurance" in the subject field.
Welcome with your application.