DSCSA Trade & Distribution Lead

Biopharma Careers; Boston (MA); Hybrid; USD 135,000 - 155,000; Full time

Job summary

Servier, a Boston-based biopharmaceutical company, seeks a Manager, U.S. Trade & Distribution to own DSCSA compliance, serialization data exchange, and ATP governance.

You will ensure traceability across 3PL and wholesalers, lead UATs for system upgrades, and collaborate with global teams to align data and regulatory requirements. The role requires 5+ years in pharmaceutical supply chain or compliance, with deep DSCSA knowledge and proficiency in TraceLink, EPCIS, and SAP/ERP systems.

Qualifications

• Bachelor’s degree required; MBA or advanced degree preferred.
• 5+ years in pharmaceutical supply chain, trade operations, or compliance.
• Proficiency in TraceLink, EPCIS data standards, and SAP/ERP systems.
• Deep understanding of the DSCSA 2023 Interoperability requirements, ATP requirements, and drop‑ship distribution models.
• Ability to interpret complex serialization exception reports and resolve data‑sharing errors with 3PLs and wholesalers in real‑time.

Responsibilities

• Serve as the primary business process owner for DSCSA compliance.
• Maintain SOPs translating DSCSA interoperability requirements.
• Oversee VRS requirements and governance of saleable returns.
• Lead UAT for DSCSA system upgrades and partner connectivity projects.
• Coordinate with Serialization Central Team for global data alignment.
• Provide oversight for EPCIS data exchanges for compliance.
• Act as SME for FDA inspections on U.S. product traceability.
• Collaborate with global partners on investigations into suspect products.
• Investigate data mismatches and drive CAPA.
• Develop and maintain ATP status documentation with Regulatory/Legal/Quality.

Skills

DSCSA compliance

TraceLink

EPCIS data standards

SAP/ERP systems

Regulatory knowledge

Data interpretation

Education

Bachelor's degree

MBA or advanced degree (preferred)

Tools

Job description

Servier, a Boston-based biopharmaceutical company, seeks a Manager, U.S. Trade & Distribution to own DSCSA compliance, serialization data exchange, and ATP governance.

You will ensure traceability across 3PL and wholesalers, lead UATs for system upgrades, and collaborate with global teams to align data and regulatory requirements. The role requires 5+ years in pharmaceutical supply chain or compliance, with deep DSCSA knowledge and proficiency in TraceLink, EPCIS, and SAP/ERP systems.