Would you like to take part in an exciting journey at a growing biotech company? SoftOx Solutions is hiring QA Director.

To strengthen the top management team and to improve the overall quality within the company, SoftOx Solutions is now hiring QA Director. The QA Director reports to CEO and is part of a diverse and international team. The position is based in Oslo.

• Manage QA systems
• Manage all quality systems at the site
• Provide training in GMP and relevant topics
• Manage QMS-reporting and -review
• Manage the GMP self-inspection program for the plant and participate as inspector
• Host and coordinate inspections by regulatory bodies or third-party customers
• Manage and support establishment, approval, and authorisation of regulatory and GMP documentation
• Head the QA/GMP team and contribute to developing strategies, priorities, and procedures within relevant quality assurance areas
• Coach and manage employees, support other managers at the plant on GMP and quality issues
• Contribute to preparing and reviewing annual product quality review on all products, and to annual reports for products marketed in the US
• Actively apply LEAN methodology to standardize processes and risk management tools to identify root-causes for negative trends and failing processes, plus implementation of CAPA
• Responsibility for EHS compliance in QA Systems, support relevant EHS processes at the site

• Master’s degree or higher in pharmacy or other relevant science
• This role requires considerable experience in quality operations and extensive cross-functional experience from the pharmaceutical industry in manufacturing/quality control/quality assurance/technical operations/R&D activities
• Broad competence in quality management, international pharmaceutical regulations and GMP standards
• Strong oral and written communication skills in Norwegian and English