Quality & Compliance Specialist – Responsible Person (RP)

• 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

• 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

Proficiency in Swedish

• 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