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Academic Work Logo Academic Work · Quality Control

Quality & Compliance Specialist – Responsible Person (RP)

Sweden, Helsingborg · Job Posted January 22, 2026
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Job Description

We are looking for an analytical and driven Quality & Compliance Specialist to act as the formally designated Responsible Person (RP) for our Swedish wholesale operations. In this business-critical position, you will ensure that our Wholesale Dealer Authorisation is maintained and that our medicinal products reach patients in a safe, compliant, and timely manner. You will join a high-performing Nordic Quality team, serving as a strategic link between global quality standards and local operational execution. This role offers significant autonomy and the opportunity to optimize Quality Management Systems within a global pharmaceutical network.

Job Responsibility

  • Act as the primary point of contact for the Swedish Medical Products Agency (Läkemedelsverket)
  • Ensure compliance with GDP regulations and manage notifications regarding product shortages
  • Implement and maintain local processes for Change Control, Non-Conformances (NC), and CAPA
  • Drive continuous improvement to ensure the QMS remains effective and aligned with business objectives
  • Oversee storage and distribution activities, qualify critical GxP suppliers (e.g., 3PL partners), and establish technical Quality Agreements
  • Define quality requirements for local value-added services such as repacking and relabelling, and approve changes to product artwork
  • Plan and execute self-inspections (internal audits) and provide lead support during Health Authority inspections and external audits
  • Coordinate any product recall operations and ensure that customer complaints are investigated, trended, and mitigated effectively

Requirements

  • University degree in Life Sciences, Engineering, or a related field required to meet the Swedish regulatory requirements for a Responsible Person (RP)
  • Proven track record in GDP (Good Distribution Practice) and Quality Assurance (QA) within the pharmaceutical industry
  • Experience working with KPI frameworks and the ability to perform "data storytelling" to visualize quality trends
  • Fluency in English is required
  • Proficiency in Swedish is a strong merit
  • Ability to exercise lateral leadership and collaborate effectively across a cross-functional network

Nice to have

Proficiency in Swedish

What we offer

  • Possibility to work remote
  • Stora möjligheter att växa professionellt och knyta värdefulla kontakter för framtiden
  • Du får en konsultchef som stöttar dig under resans gång
  • Får ta del av olika förmåner, bl.a. möjlighet till kompetensutveckling i form av en grundläggande hållbarhetsutbildning
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