Technical Project Manager, Serialization

Technical Project ManagerTechnical Project ManagerFull TimeRemoteSeniorTeam 1-10H1B No SponsorCompany SiteLinkedIn

Location

Poland

Posted

7 days ago

Salary

€4K - €6K / month

Seniority

Senior

Bachelor Degree3 yrs expSpanishItalianEnglish

Job Description

Technical Project Manager, Serialization

WhyHireWrong?

• 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

Job Requirements

  • 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

Benefits

  • Performance related bonus
  • Flexible working model (remote or hybrid)
  • Professional development through structured training and mentorship
  • Opportunities to participate in knowledge-sharing initiatives and industry events

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