Head of Global Quality Management System

1 day ago

Stockholm, Stockholm, Sweden Sobi group Full time
About the Role

We are seeking a seasoned leader to spearhead our enterprise-wide Quality Management System (QMS) strategy. As the Head of Global Quality Management System, you will be responsible for developing and implementing a comprehensive QMS strategy that ensures compliance with regulatory requirements and delivers process integrity across our global operations.

Key Responsibilities
  • Lead the development and implementation of the Global Sobi Quality Management System (QMS) strategy
  • Ensure that products, processes, systems, and procedures comply with cGxP (GMP, GDP, GVP, and GCP), as well as the Medical Device Regulation (MDR) and other relevant authority requirements
  • Lead the development, maintenance, and continuous improvement of an adaptive QMS framework to align with company strategy and Global Quality Mission
  • Proactively identify needs for standardization, regulatory compliance direction, and areas for improvement in QMS
  • Responsible for timely and strategic QMS process intelligence
  • Support digitalization of eQMS systems for a virtual setup
  • Responsible for the implementation and maintenance of Sobi Risk management process
  • Ensure strategic partnership with business partners such as GxP Process Owners, Function Leaders, and SMEs at Global and Local level
  • Establish, maintain, and continuously improve GxP processes and procedures within your area of responsibility, ensuring implementation in accordance with applicable laws and regulations and ensuring efficient and effective execution and oversight
  • Ensure integration of QMS related activities into Sobi QMS related to business integration from e.g M&A
About You

We are looking for a dynamic and experienced leader who embodies our values of Care, Ambition, Urgency, Ownership, and Partnership. The ideal candidate will have strong leadership and communication skills, be proactive and result-oriented, and possess the ability to solve complex problems. Collaboration, empathy, and cultural sensitivity are essential, along with the courage to drive change and inspire your team.

  • Minimum 15 years of experience in the pharmaceutical industry within global quality systems, quality, manufacturing, product development, and/or regulatory affairs
  • At least 10 years of leadership experience
  • In-depth knowledge of pharmaceutical and medical device regulations, including GMP, GCP, GVP, and MDR
  • Strong experience in QMS digitalization
  • Proven ability to work with high-impact stakeholders and health authorities
  • Experience with performance management, KPIs, and management reporting cycles
  • International experience and cultural awareness

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