Traceability Manager Jobs in California (NOW HIRING)

The Opportunity

We are seeking an experienced Senior Manager, Commercial Supply Chain, Serialization & Traceability to lead global serialization and traceability capabilities supporting commercial product launches and lifecycle management activities. This role is responsible for supporting compliant and scalable serialization operations across global supply networks, including CMOs, packaging sites, wholesalers, 3PLs, and external service providers. The ideal candidate will bring hands-on experience supporting or leading global serialization implementations, including EU FMD operational readiness, EPCIS data exchange, aggregation, and downstream trading partner connectivity. This role partners cross-functionally with Supply Chain, Quality, Regulatory, Packaging, Manufacturing, and IT teams to ensure compliant execution of global traceability requirements, including DSCSA, EU FMD, and emerging international regulations.

Key Responsibilities

Serialization & Traceability Operations

• Lead serialization and traceability operational readiness activities supporting commercial launches and ongoing supply operations.

• Support implementation and operationalization of global serialization and traceability requirements, including DSCSA, EU FMD, and emerging international regulations.

• Support management, investigation, escalation, and resolution of EU FMD alerts in coordination with internal stakeholders, CMOs, EMVO-connected partners, and external service providers.

• Maintain and support global GS1 registration activities, including management of company prefixes, GTIN structures, GLNs, and associated product identification data supporting serialization and traceability operations.

• Maintain oversight of serialized product onboarding, aggregation strategies, and downstream trading partner readiness activities.

• Serve as a subject matter expert for serialization operations, EPCIS data exchange, and global traceability requirements.

• Approve serialized commercial artwork, labeling implementation, and packaging change management activities.

Serialized Data Governance & Partner Management

• Oversee serialized data exchange processes among CMOs, packaging sites, logistics providers, wholesalers, and external trading partners.

• Support investigation and resolution of serialization data exchange issues, failed transmissions, aggregation discrepancies, and connectivity exceptions.

• Support operational metrics and dashboards related to serialization health, partner readiness, and data integrity.

• Partner with CMOs, 3PLs, wholesalers, and serialization service providers to ensure operational readiness and ongoing compliance.

Compliance, Documentation, & Cross-Functional Leadership

• Author and maintain serialization and traceability SOPs, work instructions, business processes, and associated documentation.

• Maintain serialization and traceability procedures, work instructions, and business process documentation.

• Own change controls and risk assessments and support audits, inspections, investigations, CAPAs, associated with serialization processes and systems.

• Serve as a central coordination point between Supply Chain, Quality, Regulatory, Packaging, Manufacturing, and IT teams for serialization and traceability initiatives.

• Support commercial launch readiness activities and continuous improvement initiatives associated with digital supply chain and traceability capabilities.

• Able to operate effectively and with a strong sense of urgency in a fast-paced environment.

Required Skills, Experience and Education:

• Bachelor's degree in Supply Chain, Engineering, Life Sciences, Information Systems, or related field.

• 8+ years of experience in pharmaceutical supply chain operations, including serialization, traceability, or commercial operations experience.

• Familiarity with serialization platforms such as TraceLink, SAP ATTP, rfxcel, or Systech and EPCIS data exchange processes and GS1 standards, including SGTIN, SSCC, GLN, and aggregation hierarchies.

• Strong knowledge of global serialization and traceability requirements, including DSCSA and EU FMD.

• Strong cross-functional leadership, communication, organizational, and problem-solving skills.

• Experience supporting serialized product onboarding and global trading partner connectivity across CMOs, wholesalers, packaging sites, and external partners.

Preferred Skills

• Direct experience supporting or leading implementation of EU FMD serialization and traceability requirements within a commercial pharmaceutical environment.

• Direct experience resolving EU FMD alerts, driving investigations, and coordinating activities across internal teams, CMOs, EMVO-connected partners, and external stakeholders.

• Deep knowledge of ERP systems, product master data structures, packaging hierarchies, and data governance processes supporting serialization operations.

• Experience managing serialized commercial artwork, labeling implementation, and packaging change management activities within a regulated pharmaceutical environment.

• GS1 Healthcare or DSCSA-related certification.

#LI-CT1 #LI-Hybrid