Quality & Compliance Specialist – Responsible Person (RP) Sweden

About the role

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.

Work tasks

As a specialist, you will combine regulatory oversight with operational quality management.

• 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.

We are looking for

• 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, as the role involves interaction with local authorities and stakeholders.
• Ability to exercise lateral leadership and collaborate effectively across a cross-functional network.

Our recruitment process

This recruitment process is handled by Academic Work and it is our client’s wish that all questions regarding the position is directed to Academic Work.

Our selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the next phase. The process includes two tests: one personality test and one cognitive test. The tests are tools to find the right talent for the right position, to enable equality, diversity, and a fair process.