Director Lab Informatics

6 dni temu

Warszawa, Mazovia, Polska UST Pełny etat 183 500 zł - 197 100 zł rocznie

Position Summary:

The Director of Lab Informatics will develop and execute a comprehensive digital strategy supporting analytical development, QC, and MSAT. This role leads lab system innovation, ensuring data integrity, operational efficiency, and regulatory compliance.

The director acts as the key liaison between scientific teams, IT, QA, and regulatory groups to deliver scalable, compliant informatics solutions.

Key Responsibilities:

Strategy & Leadership:

  • Build and execute a multi-year lab informatics roadmap aligned with digital transformation goals.
  • Identify technology gaps and drive adoption of cloud, automation, and AI solutions.
  • Guide senior leadership with insights into emerging informatics capabilities.

Project & System Ownership:

  • Oversee lifecycle management of ELN, LIMS, CDS, and SDMS.
  • Lead system selection, implementation, validation, and deployment.
  • Govern system changes, manage upgrades, and drive continuous improvement.

Operations & Compliance:

  • Ensure full compliance with global regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).
  • Support audits, inspections, risk assessments, and data governance activities.

Team & Collaboration:

  • Build and manage a high-performing, multidisciplinary informatics team.
  • Translate scientific needs into technical requirements and drive user adoption.

Strategic Initiatives:

  • Lead transition planning for technology responsibilities.
  • Accelerate LIMS 12.2 adoption and support the 21.3 upgrade.
  • Drive LIMS/SAP interface deployment and legacy LIMS decommissioning.
  • Support ELN roadmap (2026–2027), Empower/Chromeleon decision-making, and global EM rollout strategy.

Qualifications:

  • Bachelor's in Life Sciences, CS, Bioinformatics; advanced degree preferred.
  • 10+ years in lab informatics, 5+ years in leadership within pharma/biotech/CDMO.
  • Strong experience implementing GxP lab systems and managing global platforms.
  • Expertise in workflows, validation, data integrity, and project management.
  • Preferred: multi-site informatics leadership, ERP/MES/QMS integrations, AI/ML familiarity, PMP/GAMP certifications.

What We Offer:

  • Competitive compensation package.
  • Corporate learning programs and certifications.
  • Flexible working environment (remote/hybrid).
  • Career growth opportunities in a global team.

We're grateful for your interest in joining our team.
Kindly note that only applicants whose experience and qualifications most closely align with the role will be contacted for the next steps. Thank you for your understanding.

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