Quality & Compliance Specialist at Unimedic Pharma

Quality & Pharmacovigilance Department is responsible for ensuring that people with special medical needs have access to medicines of the right quality. At Unimedic Pharma, quality and compliance are an integral part of daily operations. As MAH (Marketing Authorisation Holder) for most of their product range, they bear direct responsibility for ensuring their products meet the requirements set for registered medicines – at every stage of the chain, from suppliers and wholesalers to end customers. In the role of Quality & Compliance Specialist, you will work with a wide variety of QA tasks and help drive QA operations forward. The QA & PV department consists of three colleagues and operates across the Nordic region. They are now looking for a curious and driven QA Specialist who likes to take responsibility and collaborate. About the Role As a Quality & Compliance Specialist, you will have a broad and operational role where you contribute GMP and GDP expertise to the entire organization. You will work with GxP compliance and have close collaboration with external partners and CMOs. You will serve as dRP (deputy Responsible Person) by delegation and become a key person in ensuring that operations comply with applicable regulations, including GDP guidelines, EU Regulation 2021/1248, and LVFS/HSLF-FS for wholesale distribution. You will work closely with the company's quality system – from managing and developing our eQMS to handling complaints, deviations, driving CAPA work, and conducting audits, often in dialogue with CMOs and other external partners. As part of the integration of XGX Pharma, you will also help shape how our quality systems are harmonized going forward. The role includes, among other things: Act as deputy RP and ensure compliance with GDP and relevant regulations Handle complaints, investigate deviations, and drive CAPA work and risk assessments Plan and conduct audits and qualify and follow up on external partners Participate in harmonizing quality systems as part of the XGX Pharma integration Contribute with Regulatory Intelligence Support onboarding of new partners About You We are looking for someone who feels comfortable working independently and who thrives on taking own initiative and responsibility. The role carries a certain mandate, but it's not about always having the answers right away – rather about daring to make assessments and decisions based on the knowledge you have, and seeking support when needed. You like structure and clarity, and you prefer to drive issues all the way to completion rather than just handing them off and moving on. We believe you: Have a natural science university degree, such as pharmacist, chemical engineer, or equivalent Documented experience of independently making quality decisions in a GDP/GMP environment with delegated quality responsibility At least 5 years of experience in quality work with external manufacturers (CMOs) and/or supplier and distribution chains, including qualification, quality agreements, deviation investigations, complaints, and audits Experience with quality processes in MAH operations, including PQR, recalls, and collaboration with Regulatory Affairs Strong knowledge of GDP and relevant regulatory requirements Experience developing and implementing quality systems and driving improvement initiatives at organizational level Speak and write fluent Swedish and English You have experience working in eQMS, GMP experience, and audit experience – as a participant or lead. Why This Role & Unimedic Pharma? At Unimedic Pharma, you will become part of a company in active growth, where the product portfolio is continuously expanded through acquisitions and long-term partnerships – most recently through the acquisition of Danish XGX Pharma. Our culture is built on the values of Curiosity, Courage, and Heart, which in our daily work means daring to improve processes, flagging deviations, and standing firm on quality matters. You will have a broad mandate and the opportunity to grow into the role of Deputy over time, in an organization with short decision-making paths and a coaching rather than detailed management style. We believe that the combination of clear regulations and great personal responsibility suits you if you want to develop within QA in an international environment. Application Please submit your application as soon as possible. In this recruitment, Unimedic Pharma is collaborating with SallyQ. For questions, please contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or [email protected].

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