Technical Project Manager

Unknown

RemotePosted July 27, 2026

Technical Project Manager

Unknown

RemotePosted July 27, 2026

About the role

Technical Project Manager (Serialization)

Overview: Lead end-to-end implementation and integration projects for pharmaceutical serialization systems, primarily for Spanish- and English-speaking clients and partners across Europe and Latin America. Act as a bridge between technical teams, vendors, and business stakeholders to ensure successful delivery of serialization, aggregation, and data-exchange solutions in line with GxP and GAMP5 principles.

Responsibilities

Requirements

Manage full project lifecycle for serialization and track & trace implementations from initiation to hypercare.
Serve as primary liaison between clients (MAHs, CMOs, 3PLs) and technical teams.
Coordinate integration between Level 3 (site) and Level 4 (enterprise) systems such as TraceLink, SAP ATTP, Arvato, Optel, SEA Vision, Jekson, and others.
Define and monitor project scope, timelines, deliverables, and milestones.
Conduct technical workshops, requirement gathering (URS/FDS), and validation planning (VP/IQ/OQ/PQ).
Ensure compliance with regulatory frameworks (EU FMD, DSCSA, ANMAT, COFEPRIS, AEMPS, etc.).
Prepare and review documentation: user requirements, design documents, risk assessments, and validation protocols.
Support master data and partner onboarding activities within TraceLink and national systems.
Identify project risks and dependencies, and propose mitigation strategies.
Provide technical leadership and mentorship to consultants and engineers assigned to the project.
Maintain clear and proactive communication with stakeholders in Spanish, Italian, and English.

About the role

Technical Project Manager (Serialization)

Overview: Lead end-to-end implementation and integration projects for pharmaceutical serialization systems, primarily for Spanish- and English-speaking clients and partners across Europe and Latin America. Act as a bridge between technical teams, vendors, and business stakeholders to ensure successful delivery of serialization, aggregation, and data-exchange solutions in line with GxP and GAMP5 principles.

Responsibilities

Requirements

Manage full project lifecycle for serialization and track & trace implementations from initiation to hypercare.
Serve as primary liaison between clients (MAHs, CMOs, 3PLs) and technical teams.
Coordinate integration between Level 3 (site) and Level 4 (enterprise) systems such as TraceLink, SAP ATTP, Arvato, Optel, SEA Vision, Jekson, and others.
Define and monitor project scope, timelines, deliverables, and milestones.
Conduct technical workshops, requirement gathering (URS/FDS), and validation planning (VP/IQ/OQ/PQ).
Ensure compliance with regulatory frameworks (EU FMD, DSCSA, ANMAT, COFEPRIS, AEMPS, etc.).
Prepare and review documentation: user requirements, design documents, risk assessments, and validation protocols.
Support master data and partner onboarding activities within TraceLink and national systems.
Identify project risks and dependencies, and propose mitigation strategies.
Provide technical leadership and mentorship to consultants and engineers assigned to the project.
Maintain clear and proactive communication with stakeholders in Spanish, Italian, and English.

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