Head of Global GxP Quality System and Compliance

Sobi seeks a Director to lead its Global GxP Compliance and Quality Systems team in Basel, responsible for enterprise-wide quality strategy and regulatory adherence.

This position is responsible for developing and executing a comprehensive Quality and Compliance strategy that spans all regulated processes. The incumbent will lead the global team, ensuring the effectiveness of the Quality Management System while driving a culture of excellence and transformational change.

Responsibilities

• Foster a mindset of quality excellence and drive cultural transformation across the organization.
• Guarantee the global and local effectiveness and sustainability of the Quality Management System.
• Oversee quality systems to ensure strict adherence to current GxP and regulatory standards.
• Manage budgets and timelines for the implementation and maintenance of quality-related processes.
• Provide strategic leadership to teams involved in GxP activities to ensure alignment with quality principles.
• Identify opportunities for improvement in quality processes and implement necessary steps.
• Develop and maintain risk management processes for the timely identification and reporting of risks.
• Define, approve, and manage Annual Audit Programs, including internal audits and regulatory inspections.
• Report quality system performance to senior leadership and initiate preventive and corrective actions.

Requirements

• Master’s degree in pharmacy, engineering, chemistry, or a related field.
• At least 15 years of experience in the pharmaceutical industry, covering global quality systems, manufacturing, product development, or regulatory affairs.
• Minimum of 10 years in leadership roles.
• Deep understanding of pharmaceutical and medical device businesses, including regulatory and GMP requirements.
• Proven experience with GCP and GVP regulations.
• Strong background in virtual pharmaceutical company setups and digitalization of QMS.
• Experience engaging with high-impact stakeholders, such as authorities and strategic partners.
• Proficiency in performance management, KPIs, and management cycles.
• Ability to work effectively in international, cross-border organizations.

What the company offers

• Opportunity to lead transformational change towards a culture of excellence.
• Commitment to an inclusive, sustainable, and flexible workplace that supports growth and development.

About the company

Sobi redefines standards of care and transforms the lives of people living with rare diseases. The team is diverse and entrepreneurial, passionate about growth and challenging the status quo.

• Focus on redefining standards of care for rare disease patients.
• Diverse and entrepreneurial team culture.
• Passion for growth and challenging the status quo.