Client is looking for a detail-oriented and strategic Serialization Manager to lead serialization and traceability initiatives in alignment with the FDA’s Drug Supply Chain Security Act (DSCSA). This role is critical to ensuring the integrity, safety, and transparency of the pharmaceutical supply chain. The ideal candidate will have deep expertise in serialization systems, regulatory compliance, and cross-functional project management.
Key Responsibilities
DSCSA Compliance Leadership
- Ensure full compliance with DSCSA serialization and traceability requirements across packaging, distribution, and data exchange.
- Monitor regulatory updates and proactively adjust serialization strategies to maintain compliance.
Serialization Program Management
- Oversee implementation and maintenance of serialization systems
- Manage serialization data exchange with trading partners, including EPCIS file generation and verification.
Cross-Functional Collaboration
- Partner with IT, Quality, Regulatory, and Supply Chain teams to integrate serialization into business processes.
- Liaise with contract manufacturers, third-party logistics providers, and wholesalers to ensure end-to-end traceability.
Audit & Documentation
- Maintain serialization documentation, SOPs, and validation protocols.
- Support internal and external audits related to DSCSA compliance and serialization.
Training & Support
- Train internal teams on serialization procedures and regulatory requirements.
- Serve as the subject matter expert for serialization and traceability.
Qualifications
- Bachelor’s degree in supply chain, Engineering, Life Sciences, or related field.
- 5+ years of experience in serialization, pharmaceutical supply chain, or regulatory compliance.
- Strong knowledge of DSCSA requirements, including EPCIS, product identifiers, and verification systems.
- Experience with serialization platforms.
- Excellent project management and communication skills.
- Familiarity with FDA and GMP regulations is a plus.
Salary $90,000 +/year, depending on experience plus bonus. Benefits include medical (eligible on day 1), dental, vision, 401k and vacation/holidays.
