Global Quality Systems Operations Head

Role Summary

As Head of Global Quality Systems Operations, you will set the strategic direction and ensure consistent excellence in our global quality management systems. You’ll lead the continuous improvement and digital transformation of quality processes, working collaboratively across business units and regions to support compliance, operational effectiveness, and the evolution of the Global Quality organization.

Responsibilities

• Lead and enhance the global One Quality Management System and digital platforms, driving innovation and compliance with evolving regulatory standards.
• Develop and maintain governance and business process frameworks for key quality systems, ensuring transparency, accountability, and harmonization.
• Champion a culture of collaboration, knowledge-sharing, and continuous improvement across global teams and functions.
• Provide strategic direction for the Global Business Process Ownership (BPO) framework, enabling consistent quality governance and oversight of One-QMS processes.
• Provide oversight for NorthStar Digital Quality Systems (QMS, DMS, LMS) to ensure robust digital integration and operational efficiency.
• Oversee critical quality processes (Change Control, CAPA, Documentation Management, Annual Reviews, Training), promoting adoption of digital tools and data-driven practices.
• Guide digital integration efforts for quality, documentation, and learning management systems.
• Implement monitoring mechanisms (KPIs and dashboards) to identify trends, risks, and improvement opportunities across the GxP enterprise, enabling data-driven decision-making and compliance excellence.
• Provide expertise and leadership during regulatory inspections and support health authority communications.

Qualifications

• Advanced degree in a scientific or technical field (Bachelor‚Äôs or higher) with significant leadership experience in pharmaceutical or life sciences environments.
• In-depth expertise in international quality standards, regulatory requirements, and quality systems management.
• Proven ability to lead diverse, global teams and foster cross-functional collaboration.
• Ability to drive transformation across the enterprise and elevate knowledge, capabilities, and change-readiness of collaborators.
• Strong business acumen and analytical skills to drive strategic projects and digital transformations.
• Consistent, proactive attitude, resilience, and a commitment to continuous improvement and knowledge-sharing.
• Excellent communication, stakeholder management, and team development abilities.
• Ability to present, persuade, and influence senior stakeholders in English.
• Genuine enthusiasm for innovation and digital solutions; learning agility and openness to new ways of thinking.

Skills

• Quality management systems (QMS) expertise
• Regulatory compliance and inspection readiness
• Digital transformation and data analytics
• Change management and process governance
• Cross-functional collaboration and leadership

Education

• Advanced degree in a scientific or technical field (required); additional certifications in quality or regulatory affairs are a plus.