External Quality Operations Manager

the opportunity to make a real difference for patients.  Key Qualifications  Required:  High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science  More than 5 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP)  More than 1 years of managing external quality oversight of CMOs   Curriculum is requested for evaluating the batch release qualification requirement  Fluently spoken and written English  Desired:  More than 2 years of working in global operation environment with English as a main language   Proven experience of leading Quality KPI assessment and improvement at CMOs  Proven track record with FDA; EMEA or other Health Authorities  Strong understanding of risk assessment and risk management fundamentals / tools  Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership! Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!  At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.  As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.  We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.  How to apply  We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English Why Join Us?  We are differentiating ourselves through the passion of our people, the innovative products we bring to life, and the responsible business we operate.  To ensure that more patients benefit from our therapies now and in the future, and to align with the company’s ambitions for growth, we have five core values: Care, Ambition, Urgency, Ownership and Partnership.   Our mission and purpose get us excited to come to work every day, but there are a few more reasons to join our team:  Opportunities for professional growth  Competitive compensation for your work  Diversity and Inclusion  A flexible workplace that supports work-life balance  About Sobi  Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases.  We are dedicated to capturing the scientific opportunities of our time. With our early roots in Sweden, we started as pioneers in Haemophilia. Today we are an innovate leader within rare diseases with a global reach.  We are bringing brilliant ideas to life in rare disease areas with high unmet patient needs.  We are experts on identifying breakthrough innovations, unlocking new therapies and levelling up global access to new treatments.  Our global operational network and passionate team serve as the foundation for our success.  Sobi has approximately 2,000 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, revenue amounted to SEK 28 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.