Strategic Leadership & Organizational Governance
Lead and develop a global cross-functional organization with full disciplinary and functional responsibility, including resource allocation, budget planning, and acting as the central escalation point (SPOC).
Quality Management System (QMS) Design & Development
Accountable for the design, implementation, and continuous improvement of a robust, process-based Quality Management System across all GxP areas (GMP, GVP, GCP), including core processes such as Deviation, CAPA, Change Control, and Management Review.
System Architecture & Digital Quality Infrastructure
Ensure a compliant and future-ready quality system architecture, including selection, maintenance, and evaluation of eQMS solutions as well as alignment of IT systems supporting the Science Function.
Data Integrity & Computerized Systems Compliance
Accountable for data integrity governance across all systems and documentation, including oversight of computerized system validation (CSV) and compliance with global regulatory requirements.
Quality Governance & Continuous Improvement
Lead quality governance initiatives and QMS improvement programs, ensuring continuous enhancement of system effectiveness in alignment with regulatory expectations and company quality objectives.
Cross-Functional & External Stakeholder Management
Foster cross-functional alignment across departments and serve as primary interface for escalation topics, while engaging with regulatory authorities, CMOs, suppliers, and other external partners on quality system requirements.
Capability Building & Training Excellence
Ensure organizational competency through the design and implementation of training programs and capability development initiatives for internal teams.
