Bachelor's degree in a relevant field such as science, healthcare, quality/compliance, supply chain, or distribution operations required.
Minimum of 5 years of experience in Quality Assurance, compliance, regulatory affairs or regulated distribution operations.
Minimum of 3 years of leadership experience, including direct people leadership, project leadership, or cross-functional process ownership.
Experience supporting regulated warehousing or distribution operations, including inventory control, investigations, audits, training, and quality system documentation.
Thorough knowledge of federal controlled substances regulations (21 CFR Title 21, Chapter II, Parts 1300+)
Strong knowledge of 21 CFR 210, 211, and 820; ISO 13485
Ability to use AI‑enabled tools and analytics to support controlled substance compliance monitoring, inventory anomaly detection, investigation trending, and KPI reporting, while ensuring all outputs are appropriately reviewed, validated, and compliant with regulatory, audit, and data integrity requirements.