Head of Global GxP Quality Systems

Sobi seeks a Director to lead global GxP quality systems and compliance strategy in Basel. This hybrid role oversees quality management, audits, and regulatory adherence for rare disease treatments.

The company is looking for a leader to define and execute an enterprise-wide quality and compliance strategy. This position ensures that all regulated processes meet global health authority standards while driving a culture of excellence and streamlining quality across the entire product lifecycle.

Responsibilities

• Direct the Global GxP Compliance and Quality Systems team.
• Ensure the global and local effectiveness and sustainability of the Quality Management System.
• Oversee quality systems to guarantee adherence to current GxP and regulatory standards.
• Manage budgets and timelines for the implementation and maintenance of quality processes.
• Provide strategic guidance to teams involved in GxP activities to align with quality principles.
• Identify areas for improvement in quality processes and implement corrective steps.
• Develop and sustain risk management processes for timely risk identification and reporting.
• Define, approve, and manage annual audit programs, including internal audits and regulatory inspections.
• Report quality system performance to senior leadership and initiate preventive or corrective actions.

Requirements

• Master’s degree in pharmacy, engineering, chemistry, or a related field.
• At least 15 years of experience in the pharmaceutical industry within global quality, manufacturing, product development, or regulatory affairs.
• Minimum of 10 years in leadership roles.
• Deep understanding of pharmaceutical and medical device regulations, including GMP, GCP, and GVP.
• Proven experience in virtual pharmaceutical environments and digitalizing Quality Management Systems (e.g., Veeva).
• Ability to work effectively in international, cross-border organizations.

Nice to have

• Experience in improving business practices and working procedures.
• Knowledge of pharmaceutical market dynamics and their implications.
• Track record of engaging with high-impact stakeholders, such as authorities and strategic partners.
• Experience in performance management, including KPIs and management cycles.

About the company

Sobi is dedicated to redefining care standards and transforming lives for individuals with rare diseases. The organization fosters a diverse, entrepreneurial, and inclusive culture that values growth, sustainability, and challenging the status quo.

• Commitment to transforming lives of people with rare diseases.
• Diverse and entrepreneurial team environment.
• Inclusive, sustainable, and flexible workplace.
• Focus on growth and challenging the status quo.