Technical Project Manager (Serialization)

Role Overview:

As a Technical Project Manager (Serialization), you will lead end-to-end implementation and integration projects for pharmaceutical serialization systems, primarily focusing on Spanish and Italian-speaking clients and partners. You will act as a bridge between technical teams, vendors, and business stakeholders — ensuring successful delivery of serialization, aggregation, and data exchange solutions in line with GxP and GAMP5 principles.

This role requires both technical expertise and strong communication skills, particularly in Spanish and English, to manage projects across Europe and Latin America.

Key Responsibilities:

• 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, Arvato, SAP ATTP, Optel, SEA Vision, Jekson, and others.

• Define and monitor project scope, timeline, 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 both Spanish, Italian and English.

Required Qualifications:

• Bachelor’s or Master’s degree in Engineering, Computer Science, Pharmacy, or related field.

• 3+ years of experience in pharma serialization, IT/OT integration, or supply chain compliance.

• Proven project management experience (Agile, Waterfall, or hybrid methodologies).

• Familiarity with serialization ecosystems — TraceLink, SAP ATTP, Arvato, Antares, SEA Vision, Optel, or similar.

• Strong understanding of GxP, GAMP5, CSV, and quality documentation requirements.

• Excellent communication and presentation skills in Spanish and English (C1/C2 level).

• Strong analytical and problem-solving abilities, with a structured and proactive approach.

• Experience working with global cross-functional teams.

Nice to Have:

• PMP, CAPM, or equivalent project management certification.

• Experience with Global Serialization Markets and requirements

• Technical background in SQL, APIs, or system integration.

• Knowledge of pharma packaging line systems and equipment connectivity.

• Experience working with multinational clients or complex multi-site deployments.

What We Offer:

• Work in a dynamic and international environment with top pharma companies.

• Exposure to cutting-edge serialization and compliance technologies.

• Professional development through structured training and mentorship.

• Flexible working model (remote or hybrid).

• Competitive compensation and performance-based incentives.

• Opportunities to participate in knowledge-sharing initiatives and industry events.