Civilingenjör, kvalitet, kemiteknik

At Intervacc, we are pioneering the next generation of veterinary vaccines through our proprietary technology platform. Rooted in research from the Karolinska Institute (KI) and the Swedish University of Agricultural Sciences (SLU), our mission is to reduce the impact of bacterial infections in animals through innovative, effective, and safe vaccines. Our first proprietary product — a vaccine against strangles, a serious streptococcal infection in horses— is now available in several European markets. This is just the beginning. We are expanding our reach into new territories and broadening our product portfolio. We have an exciting new opportunity for an experienced CMC Lead who will be responsible for the manufacturing and testing for the company’s marketed products, as well as the CMC-strategy for development of new vaccine products. The CMC Lead will have a central role in providing scientific guidance, support, and expertise for all CMC activities including commercial products and product under development. You will work with products in different markets to fulfill a key role within our dedicated, friendly and experienced team. If this sounds interesting to you – come join us! Intervacc AB is headquartered in Stockholm Sweden and is listed on the Swedish Nasdaq First North Growth Market. The position is full-time, and we welcome your application today! Key responsibilities As a CMC Lead, you will provide CMC strategy and expertise for our development and marketed products to ensure the company’s products are developed, manufactured, tested and maintained in compliance with global regulatory expectations, requirements and guidance. Duties and responsibilities include: Responsibility of delivering CMC-parts of development projects, launch projects as well as projects/products in commercial phase Developing CMC-strategies and ensuring oversight and planning of work performed at CROs/CMOs related to development, analytical testing and manufacturing of products Monitor KPIs and ensure timely delivery of data to support development, manufacturing and release Being responsible and promote using modern processing analytical principles such as Quality by Design, risk-based method development and data-driven decision making. Working with other internal functions as well as external suppliers and partners to ensure CMC-deliverables and resolve arising issues Participating in budget planning and monitoring Ensure compliance with global regulatory requirements and support regulatory inspections and audits Skills and Competencies The suitable candidate has the following qualifications: Formal academic degree level (MSc., Ph.D) in a science-related subject e.g. pharmacy, biology or chemistry Significant experience (more than 7-10 years) in development, manufacturing and analytical testing of biologics or biotechnology-derived products e.g. vaccines from the pharmaceutical industry Significant knowledge of the drug development and manufacturing process for biologics (including upstream and downstream processes and analytical methods) Expert knowledge in analytical and/or process development for biologics Understanding of supply planning and supplier management Knowledge of current regulatory CMC requirements, and solid knowledge in understanding of regulations and guidance for the manufacturing of biotechnology products Excellent communication and documentation skills in English are required The successful candidate for this position will be someone who: Has a solid scientific background with significant experience in processing and analytical testing of biotechnology products in combination with project management skills Is analytical, solution-oriented with a strong personal drive Is structured and organized Has a good eye for detail and a thorough approach to work Is a proactive, flexible, motivated and ambitious team player with ability to drive change If you are ready to bring your expertise within the CMC area for biologics, we are ready to offer you an excellent career opportunity at an innovative company with an exciting journey ahead! About Intervacc: Intervacc is an innovative Swedish biotechnology company that develops and markets modern, effective, and safe vaccines against bacterial infections affecting animals. Over the past decade, advances in molecular biology techniques have significantly enhanced our ability to investigate the genomes of pathogenic bacteria. Building on our research foundations at the Karolinska Institute (KI) and the Swedish University of Agricultural Sciences (SLU), we have developed a technology platform for a new generation of vaccines. Our first proprietary vaccine, a vaccine against the streptococcal infection strangles, which affects horses—is now available in several European markets. The Intervacc share (STO: IVACC) is listed on the NASDAQ First North Growth Market and our headquarter is in Stockholm, Sweden. You can find more information about Intervacc at www.intervacc.se For more information about this position, please contact: Krishan Johansson Haque, PhD Sr Recruitment Consultant, QRIOS Life Science & Engineering T: +46 (0)72-070 16 53 E: krishan.johansson-haque@qrios.se

Inossia is now recruiting a Quality Assurance (QA) Manager to the company. The position is full-time and based in our headquartered office in Stockholm and we are looking for a new colleague to join the team at Inossia. Inossia aims at improving fracture treatment for osteoporotic patients so that they can live an active life. Inossia® provides vertebral augmentation solutions that have been adapted to the mechanical properties of bone that will give Better fracture treatment for Osteporotic Bone. The company is entering a pivotal phase of its growth, with the upcoming launch of its first product and the transition from development to commercial operations. While moving toward market introduction, the company remains committed to ongoing research and development to advance solutions in spine care As a QA Manager, you will be responsible for managing our QMS and overseeing product releases. You will lead training on new SOPs and collaborate closely with our Production Manager to ensure accurate and compliant documentation. Additionally, your responsibilities will include preparing the organization for audits and conducting supplier audits. At Inossia, you will get the unique opportunity to build, shape and optimize our processes from the inside out, make a positive impact and apply your experience and expertise within QA to ensure the highest quality standards. If this sounds interesting to you - Come join us and be part of our mission of improving fracture treatment for osteoporotic patients so that they can live an active life. We will interview candidates continuously and welcome your application today! Responsibilities The QA Manager will have a central role in oversight and management of manufacturing and analytical activities from a quality perspective. You will report directly to the Director of QA/RA at Inossia. Your main responsibilities will include: Lead, maintain, and continuously improve the Quality Management System in accordance with ISO 13485 and applicable medical device regulations Ensure compliance throughout the medical device product lifecycle, from development and design through manufacturing, release, and post-market activities Oversee risk management activities, including risk files, benefit-risk analysis, and lifecycle updates Plan, conduct, and support internal and external audits, including notified body, supplier, and regulatory audits Act as a key point of contact for audit readiness, responses, and corrective actions Manage CAPA, non-conformances, deviations, and change control processes Collaborate cross-functionally to ensure quality is embedded across the organisation Support supplier quality management, qualification, and ongoing performance monitoring Ensure robust documentation control, version management, and data integrity Contribute to key strategic developments within the QA department. Your Profile Key Qualifications for the position include: Multiple years of QA experience within the medical device industry, preferably in a smaller-sized company Strong hands-on knowledge of ISO 13485 and ISO 14971 Proven experience leading and supporting audits and inspections Solid understanding of medical device quality systems, risk management, and product development processes Experience working in cross-functional, international environments Fluency in English, both in speaking and in writing We are looking for someone with a can-do attitude, strong organizational skills and a quality-driven mindset. You enjoy taking ownership and accountability to drive continuous improvement of the quality system and work well both independently and in team settings. You can handle multiple tasks and manage priorities in a timely manner and have excellent collaboration and communication skills. You are analytical, detail- and result-oriented and can effectively combine flexibility with a strong decision-making ability. Importantly, you enjoy a dynamic place of work where people matter, and your contributions will make a positive impact. If you are passionate about making a difference in the lives of patients and have the skills and experience to excel in this role, we invite you to apply today! About Inossia AB Inossia aims at improving fracture treatment for osteoporotic patients so that they can live an active life. Inossia is entering a pivotal phase of its growth, with the upcoming launch of its first product and the transition from development to commercial operations. While moving toward market introduction, the company remains committed to ongoing research and development to advance solutions in spine care Inossia has completed a clinical study of 196 patients in 4 countries and 9 clinics Inossia received the Breakthrough Device Designation for Inossia Cement Softener in June 2025 To learn more, please visit www.Inossia.com For more information about the position, please contact: Krishan Johansson Haque, PhD Sr Recruitment Consultant, QRIOS Life Science & Engineering T: +46 (0)72-070 16 53 E: krishan.johansson-haque@qrios.se

Vi söker dig som har en ingenjörsexamen eller motsvarande och minst fem års erfarenhet inom kvalitetssäkring av produkter och processer. Rollen innebär att säkerställa att utveckling och tillverkning följer ISO 13485, GMP och interna kvalitetsstandarder, samtidigt som förbättringsarbete och riskhantering drivs framåt. Erfarenhet av teknisk dokumentation är central, där spårbarhet, korrekthet och fullständighet upprätthålls genom hela produktlivscykeln. Kompetens inom avvikelsehantering behövs för att utreda orsaker, genomföra analyser och säkerställa effektiva CAPA‑åtgärder. Rollen omfattar även granskning och bedömning av interna processer och leverantörer samt stöd vid externa revisioner för att säkerställa högsta nivå av compliance. Du behärskar svenska och engelska obehindrat, både i tal och skrift. Som konsult hos QRIOS Life Science & Engineering får du arbeta med spännande uppdrag inom MedTech och Pharma hos både stora och små aktörer. Här utvecklas du snabbt, och har stöd av ett erfaret QRIOS‑team i ryggen. I Malmö är vi 20+ specialister inom projektledning, kvalitet och mekanik, många med över tio års erfarenhet. Vi tror på att leverera på topp utan att kompromissa med livet utanför jobbet. Det kallar vi Work‑Life‑Passion, en kultur där både prestation och välmående får plats.

Vi söker nu fler QA-profiler inom Life Science till vårt nätverk i Stockholm/Uppsala. Vi arbetar löpande med uppdrag hos några av regionens mest spännande läkemedels- och medicinteknikbolag – och vill nu komma i kontakt med dig som har erfarenhet av kvalitetssäkring i GMP-reglerad miljö. Om rollen Som QA Specialist arbetar du nära produktion, tekniska funktioner och projektteam för att säkerställa att processer, system och produkter uppfyller gällande regulatoriska krav. Arbetsuppgifter kan inkludera: Avvikelsehantering (deviations), CAPA och change control Granskning och godkännande av dokumentation (SOP, batch records m.m.) Deltagande i audits (interna/externa) Stöd i kvalitetsledningssystem (QMS) Säkerställa efterlevnad av GMP. Vi söker dig som: Har erfarenhet av QA inom Life Science Har god kunskap om GMP och regulatoriska krav Har arbetat med deviation/CAPA/change control Talar svenska och engelska flytande. Vi arbetar både med konsultuppdrag och rekryteringar och tar gärna en dialog kring dina preferenser. Urval sker löpande och eftersom detta är en proaktiv annons så återkopplar vi så snart som möjligt.