Description:
The QA Compliance Specialist - Controlled Substances oversees quality and compliance activities related to the storage, handling, and distribution of controlled substances within Distribution Centers. The role ensures compliance with federal and state-controlled substance regulations through cross‑functional collaboration, leadership, decision‑making, training, and issue resolution, often without onsite supervision.
Key Responsibilities
- Manage site quality systems and processes related to the storage, handling, and distribution of controlled substances.
- Ensure policies and procedures are in place for inventory control, documentation, reporting, investigations, training, and audits related to controlled substances.
- Partner with Operations to manage day‑to‑day distribution center activities and ensure compliance with all applicable laws, regulations, and procedures.
- Lead or approve controlled substance nonconformance investigations, track KPIs, drive continuous improvement initiatives, and support additional distribution centers as needed.
- Lead inspection readiness initiatives, including mock audits and compliance training.
- Serve as the primary interface with regulatory agencies (e.g., DEA) for inspections and regulatory inquiries.
Minimum Job Qualifications:
- Bachelor’s degree in a relevant field such as science, healthcare, quality/compliance, supply chain, or distribution operations required. Advanced degree preferred.
- 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.
- Experience with pharmaceutical distribution, controlled substance compliance, and inspections by regulatory agencies such as DEA, FDA, or State Boards of Pharmacy preferred