• BS/MS degree in a scientific discipline.
• 10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years in leadership roles within Quality or related functions.
• Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development.
• Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.
• Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.
• Hands-on experience with systems such as Veeva Vault is preferred.
• Highly proactive, decisive, and capable of independently managing key initiatives.