Director, GxP Quality Assurance

• Lead the development and scaling of a GxP Quality Management System
• Building a fit-for-purpose GxP Quality Management System: Develop and maintain a scalable QMS, govern GxP policies and SOPs, act as system owner for electronic quality systems, and drive quality metrics, management reviews and continuous improvement
• Providing integrated GxP QA oversight across drug development: Lead GCP QA as Gubra enters clinical development, ensure coherent GxP governance across clinical, CMC and non-clinical programs, and drive inspection readiness in alignment with ICH E6(R3)
• Managing vendors and audit programs: Oversee risk-based auditing of CROs, clinical sites, and CMC partners
• Strengthen quality systems, training and culture: Improve and oversee deviation, CAPA and change control processes with robust root-cause analysis, ensuring cross-functional alignment and reporting key quality metrics

• 10+ years of GxP QA experience in biotech or pharmaceutical industry
• BS or higher degree in life sciences
• In-depth knowledge of global GCP regulations with a minimum of 5 years of experience in GCP QA leadership
• Strong working knowledge of GMP and GLP
• Experience scaling a QMS in a growing biotech is highly desired
• Experience with audits and QA oversight of third-party vendors, clinical sites and internal systems and processes, either hands-on or through collaboration with external auditors or consultants
• Strong understanding of computerized system validation (CSV) and data integrity principles

Experience adapting QMS to regulatory changes (e.g., ICH E6(R3)) is highly desired