Global Quality Country Organization Head

Global Quality Country Organization Head

Sobi

Basel or Stockholm

Job Description

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 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.

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 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.

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