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Senior Consultant/Serialization Specialist

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Life Science Talent

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Location:
Denmark , Region Hovedstaden

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

We are looking to strengthen our team in Denmark with a Senior Consultant / Serialization Specialist, who can help our clients navigate the increasingly complex landscape of pharmaceutical serialization and compliance. Are you passionate about compliance, Computer Systems Validation (CSV), and serialization in the Life Sciences industry? Do you enjoy working at the intersection of IT, quality, and regulatory requirements—while advising clients on critical, business-impacting solutions? Then you could be our new colleague.

Job Responsibility:

  • Acting as SME within Serialization, supporting implementation, rollout, and optimization of serialization solutions
  • Leading and supporting Computer Systems Validation (CSV) activities for serialization and related systems
  • Defining and implementing compliance strategies aligned with global regulatory requirements
  • Supporting IT/QA readiness assessments and developing validation approaches
  • Advising clients on serialization regulations (e.g., EU FMD, US DSCSA) and industry best practices
  • Driving vendor selection, evaluation, and oversight for serialization platforms
  • Supporting integration of serialization systems with ERP, MES, and other enterprise systems
  • Acting as a trusted advisor on compliance, quality, and governance within serialization programs
  • Facilitating workshops with business, IT, and quality stakeholders
  • Supporting audits and inspections related to serialization and validated systems

Requirements:

  • 5+ years of experience within IT compliance, serialization, CSV, or similar roles in the Life Sciences industry
  • Hands-on experience with serialization systems (e.g., Level 3/4 solutions, reporting systems, integration layers)
  • Strong knowledge of Computer Systems Validation (CSV) and/or Computer Software Assurance (CSA)
  • Solid understanding of relevant regulations such as: EU GMP Annex 11, FDA 21 CFR Part 11, GAMP5, Serialization regulations (EU FMD, US DSCSA)
  • Experience working with regulated IT systems and compliance frameworks
  • A strong consultancy mindset with excellent communication and stakeholder management skills
  • Ability to translate complex regulatory requirements into practical, business-oriented solutions
  • Experience working across IT, Quality, and Business domains
  • Ability to manage multiple tasks and projects while maintaining high quality
  • A proactive, collaborative, and solution-oriented approach
  • A commercial mindset with motivation for recognizing client opportunities and bringing them to our sales team

Additional Information:

Job Posted:
May 05, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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