Director, Quality Systems

Role: Director of Quality Systems overseeing QA functions for Viking’s clinical and commercial-stage operations, ensuring compliance, inspection readiness, and scalable quality processes. Responsibilities: lead and manage the QS team; develop and maintain QMS aligned with GMP, FDA, ICH, and ISO standards; oversee document control, change management, and electronic QMS (Veeva); prepare for regulatory inspections; manage CAPAs, deviations, and continuous improvement initiatives; support CMC regulatory submissions; and partner cross-functionally across R&D, manufacturing, and regulatory teams. Requirements: Bachelor's in Life Sciences, Engineering, or related field; 10+ years in QA with at least 5 years in leadership within regulated pharma/biotech or med device industries; deep knowledge of GMP, FDA regulations, ICH guidelines, and QMS design; experience with eQMS platforms like Veeva; strong leadership, communication, and audit management skills. HighValue: 10+ years QA experience, GMP/FDA compliance, QMS design, electronic quality systems (Veeva), Quality Risk Management, and experience supporting CMC and regulatory inspections. WorkSetup: not specified; likely office-based with leadership responsibilities.