External Quality Assurance Manager for Pharmaceuticals

14 hours ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

About Sobi

Sobi is a global leader in the development and commercialization of innovative treatments for rare and debilitating diseases. Our company operates in over 30 countries, employing over 1,800 talented individuals who share our passion for making a difference.

We value diversity and inclusion in our workplace and strive to create an environment that fosters collaboration, innovation, and growth. If you are a driven and motivated professional looking to contribute to a dynamic team, we would love to hear from you.

About the Role

We are seeking an experienced External Quality Assurance Manager for Pharmaceuticals to join our team. This role involves overseeing product release, supplier qualifications, and quality technical agreements to ensure compliance with GMP & GDP regulations and Sobi's quality system.

Your Key Responsibilities

  • Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
  • Oversee product release, supplier qualifications, and quality technical agreements.
  • Implement and maintain quality risk assessments and KPIs.
  • Manage quality issues, audits, and change requests.
  • Lead quality initiatives and act as a quality representative in projects.

Requirements

  • Degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science, including courses in inorganic, organic, analytical, physical, and medical chemistry, biochemistry, physiology, galenic pharmacology/pharmaceutical technology, pharmacology, and toxicology.
  • More than 10 years of experience within pharmaceutical, biotech products. More than 5 years of experience in QA operation or external quality including supplier quality management (GMP, GDP).
  • In-depth understanding of GMP requirements of FDA; EMEA, or other Health Authorities.
  • Strong understanding of risk assessment and risk management fundamentals/tools.
  • Excellent verbal and written communication skills.
  • Fluently spoken and written English.


  • Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

    About SobiSobi is a global biopharmaceutical company dedicated to transforming the lives of people with rare and debilitating diseases. Our mission is to provide reliable access to innovative medicines in areas such as haematology, immunology, and specialty care.As a key player in the industry, we are committed to our core values: Care, Ambition, Urgency,...


  • Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

    About SobiSobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. We are dedicated to providing reliable access to innovative medicines in areas such as haematology, immunology, and specialty care.We live by our core values: Care, Ambition, Urgency, Ownership, and Partnership. These...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Job DescriptionKaro Healthcare is a leading provider of healthcare solutions with a strong presence in the European market. We are seeking a highly skilled Quality Assurance Manager to join our team.The successful candidate will be responsible for ensuring the quality and compliance of our products, working closely with suppliers, manufacturers, and internal...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Job DescriptionThe Quality Assurance Specialist will ensure compliance with Haleon standards and policies, as well as GDP and local regulatory requirements.Key responsibilities include:Performing Duty of Care activities for finished products to the local market after EU certification.Managing complaints and engaging in the maintenance of the local...


  • Stockholm, Stockholm, Sweden Sobi Middle East FZ LLC Full time

    About the Job DescriptionThe Quality Supplier Manager plays a critical role in ensuring compliance with current GMP & GDP regulations, the Quality Technical Agreement, and Sobi procedures and policies. As a single point of contact with the external supplier, this role requires strong communication and collaboration skills to foster effective decision-making...


  • Stockholm, Stockholm, Sweden Sobi Middle East FZ LLC Full time

    About the RoleWe are seeking a skilled Global Quality Assurance Manager to oversee quality-related activities with external suppliers. This is an excellent opportunity for you to utilize your expertise in GMP and GDP regulations, as well as your experience in QA operations and supplier quality management.As a Global Quality Assurance Manager, you will serve...


  • Stockholm, Stockholm, Sweden Nordberg Medical Full time

    As a highly organized and detail-oriented Quality Assurance Professional, you will work closely with production teams to enhance processes, facilitate batch releases, and manage deviations and CAPA to ensure compliance and continuous improvement within the QA field.Key ResponsibilitiesYour key responsibilities will include reviewing batch records and...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    About the RoleThe Quality Assurance Specialist will play a key role in ensuring compliance with Haleon standards and policies, as well as GDP and local regulatory requirements.Key Responsibilities:Perform Duty of Care activities for finished products to the local market after EU certification.Manage complaints and engage in the maintenance of the local...


  • Stockholm, Stockholm, Sweden SEB group Full time

    About the RoleAs a seasoned Quality Assurance Manager, you will play a vital part in our community driving the Test & Quality agenda in the Accounts & Payments domain. You will be responsible for coordinating end-to-end, external, and performance tests, ensuring quality outcomes through effective methodologies and tools.You will also support feature teams in...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    We are looking for a seasoned professional to fill the role of Quality Assurance Operations Manager at PharmaRelations ApS. This position plays a critical role in ensuring the quality of our products and adhering to industry standards.Main Responsibilities:Oversee the implementation of GMP/GDP regulations across our supply chain, guaranteeing...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Job OverviewKaro Healthcare is a leading provider of healthcare solutions with a strong presence in the European market. We are seeking a highly skilled Pharmaceutical Quality Control Lead to join our team.The successful candidate will be responsible for ensuring the quality and compliance of our products, working closely with suppliers, manufacturers, and...


  • Stockholm, Stockholm, Sweden Recipharm AB Full time

    **About the Role**We are seeking a highly motivated QA Specialist to support our Quality Management System (QMS) processes in RPH Pharmaceuticals. As a QA Specialist, you will be responsible for managing and maintaining our eQMS, ensuring compliance with Global Quality requirements.Main Responsibilities:Lead GxP Training and perform SOP training in the...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    At PharmaRelations ApS, we are seeking a highly skilled Senior Pharmaceutical Quality Specialist to support the overseeing of external suppliers for manufacturing activities, ensuring compliance with GMP/GDP regulations.About the Role:Review batch records to support batch release and ensure adherence to quality systems.Ensure compliance with QTAs and GMP/GDP...


  • Stockholm, Stockholm, Sweden Ascentic AB Full time

    About UsAscentic AB is a software development partner based in Colombo, Sri Lanka. Founded in 2017, we support Swedish clients with their software needs, scaling up into a stable company with over 110 employees.We are now expanding our business in Sweden and looking for a Quality Assurance Manager to join our team. The ideal candidate will have confidence in...


  • Stockholm, Stockholm, Sweden CO-WORKER TECHNOLOGY Full time

    About CO-WORKER TECHNOLOGYWe are a leading technology company seeking a highly skilled QA Test Lead to join our team. As a Quality Assurance Manager, you will be responsible for developing and implementing effective test strategies, ensuring high-quality software releases.


  • Stockholm, Stockholm, Sweden Tobii Dynavox® Full time

    At Tobii Dynavox, we empower people with disabilities to do what they once did or never thought possible. We call this mission Power to Be You. Our assistive communication technology helps our customers express themselves, connect with the world, and pursue independence.About the Role:We are seeking a highly skilled Global Quality Management System Manager...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Role OverviewKaro Healthcare is a dynamic and growing company that prioritizes making smart choices for everyday healthcare. With a diverse portfolio of over 80 brands in about 90 countries, we empower people to make intelligent health decisions. Our growth strategy combines organic expansion and mergers and acquisitions.We're currently seeking a Quality...


  • Stockholm, Stockholm, Sweden NCC Full time

    We are seeking a highly skilled Data Quality Assurance Manager to join our Data Management Team. As a key member of the team, you will be responsible for ensuring the accuracy and reliability of our organization's data. This includes developing and implementing data quality management processes, monitoring data quality metrics, and identifying areas for...


  • Stockholm, Stockholm, Sweden Paradox Interactive Full time

    We are looking for a seasoned Quality Assurance Expert to join our team at Paradox Interactive, focusing on the quality assurance of our grand strategy game Stellaris. As a key member of our QA team, you'll work closely with developers and other stakeholders to ensure the game meets the high standards of quality our players expect.About the RoleDevelop...


  • Stockholm, Stockholm, Sweden Senterprise Sverige AB Full time

    About the Role:We are seeking a Warehouse Project Manager - Quality Assurance Specialist to join our team at Senterprise Sverige AB. The ideal candidate will have experience in warehouse management, quality assurance, and supply chain operations.Responsibilities:Manage Warehouse Operations: The candidate will be responsible for managing warehouse operations,...