Head of Global GxP Quality Systems

Sobi is hiring a Head of Global GxP Quality Systems to lead the organization’s global quality management and compliance strategy across regulated activities. This senior leadership role is responsible for strengthening quality systems, ensuring compliance with global regulatory standards, driving continuous improvement initiatives, and fostering a culture of quality excellence across the product lifecycle. The position offers the opportunity to work in an international environment while supporting the development of treatments for rare diseases.

Location: Stockholm, Sweden (Remote Available)
Employment Type: Full-time
Company Location: Switzerland

Key Responsibilities

• Lead the Global GxP Compliance and Quality Systems team while providing strategic direction across global quality operations.
• Oversee the effectiveness, sustainability, and continuous improvement of the Global Quality Management System (QMS).
• Ensure compliance with current GxP regulations and global health authority requirements across business operations.
• Develop and implement enterprise-wide quality and compliance strategies covering regulated processes across global functions, affiliates, partners, and service providers.
• Manage quality-related budgets, project timelines, and implementation of quality processes.
• Drive quality risk management initiatives, identify improvement opportunities, and support continuous process optimization.
• Lead internal audits, regulatory inspection readiness, audit programs, and follow-up corrective actions.
• Report quality system performance to senior leadership and recommend preventive and corrective actions to maintain compliance.

Requirements

• Master’s degree in Pharmacy, Engineering, Chemistry, or a related scientific discipline.
• Minimum of 15 years of experience in the pharmaceutical industry within Quality Systems, Manufacturing, Product Development, Regulatory Affairs, or related functions.
• At least 10 years of leadership experience managing global quality teams.
• Strong knowledge of GMP, GCP, GVP, medical device regulations, and global pharmaceutical compliance requirements.
• Experience working with digital Quality Management Systems such as Veeva or similar enterprise platforms.
• Proven experience working with international stakeholders, regulatory authorities, and strategic business partners.
• Strong leadership, communication, collaboration, and problem-solving abilities.
• Ability to drive organizational change, performance management, and continuous improvement initiatives in a global environment.