Global Quality Country Organization Head

Reporting 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 Sobis overall business strategy. You will proactively manage opportunities and risks throughout the lifecycle of Sobis products ensuring compliance with GxP regulations local requirements and Sobis 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 Sobis 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 followups.
• Foster efficiency quality improvements and costconsciousness 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.

Qualifications :

You 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 actionoriented 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 highimpact stakeholders and manage strategic priorities effectively. Your leadership style fosters motivation trust and continuous improvement ensuring operational excellence in everything you undertake.

Key Qualifications

• Masters 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 Information :

How to apply
At Sobi we value worklife 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 teamoriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Competitive compensation for your work
• Making a positive impact to help ultrarare disease patients who are in need of life saving treatments

We are a global company with over 1800 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed firsthand 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 groundbreaking 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 cant 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.

Remote Work :

No

Employment Type :

Fulltime