Head of Global GxP Quality System and Compliance

This is a fully remote position, open to applicants in Sweden.

📋 Description

• The Global GxP Quality Systems Head is responsible for collaborating across the organization (both globally and locally) to create and implement a comprehensive Quality and Compliance strategy that encompasses all regulated processes performed by Sobi functions, Affiliates, service providers, and partners, ensuring compliance with global health authority standards throughout the product lifecycle.

• Leading the Global GxP Compliance & Quality Systems team.

• Tasked with promoting a mindset of Quality & Compliance Excellence, this role presents a unique opportunity to spearhead transformational changes towards a culture of excellence and to work with the Global Quality organization to streamline and simplify processes by adopting an integrated approach to quality and compliance across the product lifecycle.

• Accountable for the effectiveness and sustainability of the Global Sobi Quality Management System at both global and local levels.

• Responsible for overseeing the quality system and ensuring compliance with current GxP and regulatory standards.

• Tasked with establishing and maintaining budgets and timelines, and supervising the implementation and upkeep of quality-related processes.

• Expected to provide leadership and strategic direction to teams engaged in GxP-related activities to ensure compliance with quality strategy principles and processes, and to take necessary actions to maintain company-wide compliance.

• Responsible for overseeing quality-related processes, and in collaboration with Global Process Owners, identifying areas for improvement and implementing steps to enhance them, with a continual focus on refining strategies and tools.

• Accountable for developing, implementing, and sustaining a risk management process for the timely identification and reporting of risks, thereby maintaining a Quality Risk Management concept.

• Responsible for defining and approving Annual Audit Programs and for the preparation, execution, hosting, and follow-up of internal audits and regulatory inspections.

• Tasked with providing strategic direction and regularly reporting the performance of the quality system and related procedures to Sobi Senior Leaders, while also initiating preventive and corrective measures to prevent the recurrence of deviations or non-conformances.

⛳️ Requirements

• Master’s degree in pharmacy or a related field (Engineering, Chemistry, etc.).

• At least 15 years of experience in the pharmaceutical industry, specifically within global Quality systems, Quality, Manufacturing, Product development, and/or Regulatory affairs.

• A minimum of 10 years of leadership experience.

• Understanding of the pharmaceutical and medical device sectors, including thorough knowledge of regulatory and GMP requirements, with experience in GCP and GVP regulations.

• Proven experience in enhancing business practices and working procedures.

• Strong background working in a virtual pharmaceutical company environment and with digitalization for Quality Management Systems (e.g., Veeva or other global systems).

• Insight into the interrelations and implications within the pharmaceutical market.

• Experience engaging with high-impact stakeholders, such as authorities and strategic business partners.

• Familiarity with establishing and managing performance management systems, KPIs, and the management cycle.

• Experience working in an international organization and across borders.

• Strong leadership and communication skills.

• Proactive mindset and actions, along with strong interpersonal and collaboration capabilities, result-oriented, and adept at solving complex issues and managing conflicts to create win-win situations.

• Cultural awareness and understanding of behaviors in diverse cultures.

• Comprehensive business understanding.

• Possesses courage, empathy, trust, and motivation.

🏝️ Benefits

• Flexible workplace.

• Professional development.