• Manage document control activities within the electronic document management system (EDMS) (i.e., Veeva Quality Suite), related to Phase III and Commercial readiness associated GXP (i.e., Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP)) documentation • Play a critical role in ensuring that Apogee maintains the highest standards of document management and regulatory compliance • Support cross functional teams’ success in the advancement through every stage within the document lifecycle • Maintain document control policies, procedures, and systems in accordance with GXP regulations • Utilize Veeva Systems as a centralized EDMS for GXP documentation and employee training • Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records • Conduct regular audits (“data cleaning”) of GXP documents and training processes and documents/records to identify, address, and correct discrepancies and or non-compliance issues to ensure accuracy and “system wellness” • Maintain robust quality control measures for all GXP documents • Leverage experience with Veeva Systems to optimize document management processes and workflows • Provide guidance and training to staff on using Veeva for document control and compliance purposes • Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, EMA, ICH) • Work in partnership with various departments (e.g., Biometrics, Clinical, IT, Legal, Nonclinical, Program Management, Regulatory Affairs, Technical Operations, etc.) to ensure GXP document accuracy and relevance • Identify opportunities for improvements in GXP document and record control practices