Director, Supply and Distribution Quality
Core
Lead Quality oversight across an outsourced commercial pharmaceutical supply network, covering packaging, labeling, storage, transportation, distribution, serialization, and product traceability.
Role type
Director, Supply and Distribution Quality
Builds
Compliant, secure, and reliable product supply for commercial launches and lifecycle management
Domain
Pharmaceutical industry, commercial supply chain, GMP Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality oversight & compliance)
Required skills
Pharmaceutical GMP expertise, external partner governance, packaging and labeling controls, DSCSA compliance, serialization and traceability, risk-based decision-making, regulatory inspection readiness, supplier qualification and audit, CAPA management, controlled substance distribution
Preferred skills
Commercial product launches, 3PL implementation, distribution-lane qualification, mock recalls, serialization platforms, FDA/state regulatory inspections, small-molecule oral solid dosage products
Technologies
Serialization platforms, traceability-data exchange systems, quality management systems
Responsibilities
Provide Quality leadership for commercial packaging and labeling activities; Serve as Quality relationship owner for external partners; Approve packaging artwork and labeling components from a GMP perspective; Oversee Quality readiness and lifecycle management for outsourced packaging; Review final batch records and make release-to-market decisions; Lead Quality oversight for storage, transportation, and distribution activities; Drive Quality readiness for commercial launch including 3PL onboarding; Establish risk-based oversight of 3PLs and distributors; Oversee logistics-related quality events; Coordinate investigations and product-impact assessments; Serve as Supply Quality lead for recalls and market actions; Lead the DSCSA Quality compliance program; Provide Quality governance for serialization platforms; Lead investigations involving suspect or illegitimate products; Monitor evolving regulatory requirements; Own and improve procedures for distribution quality and traceability; Represent Quality in external partner meetings; Lead inspection readiness for regulatory authorities; Track and report quality and compliance indicators; Establish functional strategy and resource plans; Influence internal stakeholders and external partners
Seniority
Director, strategic leadership with operational oversight
