Company DescriptionStatistics 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.Job DescriptionReporting to Global QA E2E, the Global Quality Country organization Head is responsible for leading the development of a consistent Quality Culture through all affiliates. the Incumbent ensures Country Quality Organization and quality systems & processes are in place to best support overall Sobi business strategy.In this role, you will develop and embed a consistent Quality Culture across all affiliates, ensuring that robust quality systems and processes are in place to support Sobi’s overall business strategy. You will proactively manage opportunities and risks throughout the lifecycle of Sobi’s products, ensuring compliance with GxP regulations, local requirements, and Sobi’s Quality Manual.As a key member of the Global QA E2E leadership team, you will collaborate across functions to foster operational excellence and continuous improvement while maintaining the highest quality standards. The role can be located in Stockholm, Sweden and Basel, Switzerland.Key Responsibilities:

• Build and lead a consistent Quality Culture across all affiliates, ensuring Country Quality Organization is in place to best support Sobi’s business strategic goals.
• Oversee the implementation of global quality systems, regulatory standards, and governance processes.
• Ensure compliance with GxP standards and local regulations, while monitoring key quality indicators.
• Collaborate with global and local teams to resolve escalations,
• Ensure adequate preparation for local regulatory inspections and manage follow-ups.
• Foster efficiency, quality improvements, and cost-consciousness across the organization.
• Engage with Health Authorities, ensuring commitments are aligned, tracked, and closed effectively.
• Drive global initiatives and support affiliates with onboarding, training, and risk mitigation.

QualificationsYou are a strong and inspiring leader with excellent communication and collaboration skills, capable of building trust and driving results across global teams. A proactive and action-oriented mindset defines your approach, coupled with a strong sense of ownership and accountability. You excel at solving complex challenges and navigating diverse cultural contexts, demonstrating empathy, courage, and integrity in all you do. With a keen business acumen, you have a natural ability to engage with high-impact stakeholders and manage strategic priorities effectively. Your leadership style fosters motivation, trust, and continuous improvement, ensuring operational excellence in everything you undertake.Key Qualifications

• Master’s degree/PhD in Pharmacy, Engineering, Chemistry, or a related field.
• Minimum 15 years of experience in the pharmaceutical industry in quality, manufacturing, or regulatory affairs.
• At least 10 years of leadership experience in international, matrixed organizations.
• Deep understanding of global regulatory and GxP requirements across markets (US, EU, APAC, LATAM, MENA).
• Proven success in performance management, KPI implementation, and lifecycle management.
• Expertise in GVP and GCP, with a track record of driving business improvements and working with strategic stakeholders.

Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership!Additional InformationHow to apply
At Sobi, we value work-life balance and due to the holidays, it may take a little bit longer until you hear back from us.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?Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Competitive compensation for your work
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

We are a global company with over 1,800 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others› lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.Sobi CultureAt Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.