Quality Assurance Lead Clinical Trials

1 day ago


Stockholm, Stockholm, Sweden Sobi, Inc Full time

We are seeking an experienced Clinical Quality Assurance Manager to join our team at Sobi, Inc. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and leadership.

The Clinical Quality Assurance Manager will be responsible for ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) throughout their lifecycle. This includes developing and implementing quality strategies, managing supplier relationships, and ensuring adherence to regulatory requirements.

Key Responsibilities

  • Develop and implement quality strategies to ensure the quality and compliance of IMPs.
  • Manage supplier relationships to ensure timely delivery of high-quality IMPs.
  • Ensure adherence to regulatory requirements, including GMP & GDP and GCP.
  • Oversee batch record reviews and release for IMPs across US, EU, and RoW clinical trials.
  • Monitor and manage key performance indicators (KPIs) related to IMP supplier quality.

Required Skills and Qualifications

  • Bachelor's degree or equivalent education/degree in life sciences.
  • Minimum (10) years of experience within pharmaceutical, biotech product.
  • Relevant experience from working with quality aspects of medicinal products in clinical trials, especially batch allocation and supply to clinical trials.
  • Extensive experience in QA operation, production or other relevant area (GMP, GDP).
  • Strong working knowledge of US and European regulations, with emphasis on Annex 13, and preferably other regions such as APAC and LATAM.
  • Strong understanding of risk assessment and risk management fundamentals/tools.
  • Fluently spoken and written English.

About the Role

  • This is an exciting opportunity to join a dynamic team at Sobi, Inc.
  • You will have the chance to make a meaningful contribution to the development of high-quality Investigational Medicinal Products (IMPs).
  • You will work closely with cross-functional teams to ensure the quality and compliance of our IMPs.
  • You will have opportunities for professional growth and development.

Company Overview

Sobi, Inc. is a leading developer of Investigational Medicinal Products (IMPs). Our mission is to deliver high-quality products that meet the needs of patients worldwide.



  • Stockholm, Stockholm, Sweden Sobi, Inc Full time

    About Sobi, Inc.Clinical Quality Assurance ManagerAt Sobi, Inc., we are committed to delivering high-quality Investigational Medicinal Products (IMPs) that meet the highest standards of quality and compliance. As a Clinical Quality Assurance Manager, you will play a pivotal role in ensuring the quality and compliance of our IMPs through your leadership and...


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

    Quality Assurance RoleThe Clinical Quality Assurance Manager will oversee the quality and compliance of Investigational Medicinal Products (IMPs) through leadership and guidance of supplier management teams.Key Responsibilities:Ensure quality assurance and compliance across all aspects of IMPs.Develop and implement quality systems and procedures to ensure...


  • Stockholm, Stockholm, Sweden Syneos Health, Inc. Full time

    Syneos Health is a global organization operating in over 45 countries, bringing clinical research directly into the home of the patient to improve the experience of patients involved in clinical trials and the quality of their lives.We are committed to building a diverse, inclusive, and authentic workplace where everyone has the opportunity to succeed. If...


  • Stockholm, Stockholm, Sweden Collective Minds Radiology Full time

    About UsAt Collective Minds Radiology, we are redefining how imaging is used in research. Our community-driven platform is built for collaboration, knowledge-sharing, and transforming clinical trial workflows. We work alongside CROs, pharma, eClinical firms, and MedTech companies to improve imaging workflows, compliance, and trial efficiency.We are a company...


  • Stockholm, Stockholm, Sweden Collective Minds Radiology Full time

    Sales Executive –Medical Imaging Software for Clinical TrialsAre you an experienced sales professional with a background in clinical trial data managementand healthcare technology, with a proven track record of consultative selling and closing deals in B2B environments?Do you have a deep understanding of how clinical trials are conducted, the role of data...


  • Stockholm, Stockholm, Sweden Sobi, Inc Full time

    We are seeking a highly skilled and experienced Clinical Quality Assurance Manager to join our team at Sobi, Inc. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and leadership.The Clinical Quality Assurance Manager will be responsible for ensuring the quality and compliance of our Investigational Medicinal...


  • Stockholm, Stockholm, Sweden Syneos Health, Inc. Full time

    At Syneos Health, we offer a range of clinical research nursing opportunities that allow you to work with patients in their homes across Sweden.We are seeking motivated and enthusiastic nurses who combine high-quality clinical skills with a compassionate, engaging personality and a dedication to ensuring exceptional patient outcomes.Key...


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

    Job SummaryThe Clinical Quality Assurance Manager will be responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through leadership and guidance of supplier management teams.Key Responsibilities:Provide quality assurance and compliance expertise to ensure adherence to regulatory requirements.Develop and implement...


  • Stockholm, Stockholm, Sweden RPS Softwares AB Full time

    Are you a seasoned Quality Assurance Lead looking for a new opportunity? We are seeking a highly skilled professional to lead the end-to-end testing of our Warehouse Project. In this role, you will be responsible for managing multiple test phases, maintaining quality standards, and ensuring timely execution of the testing strategy.The ideal candidate will...


  • Stockholm, Stockholm, Sweden Sobi, Inc Full time

    About Sobi, Inc.Clinical Quality Assurance ManagerWe are seeking a highly skilled and experienced Clinical Quality Assurance Manager to join our team at Sobi, Inc. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and leadership.The Clinical Quality Assurance Manager will be responsible for ensuring the quality...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Our mission is to provide reliable access to innovative medicines in the areas of haematology, immunology, and specialty care.Job Overview:The Quality Assurance Lead will be responsible for managing the quality interface and...


  • Stockholm, Stockholm, Sweden Götgatan - Stockholm Full time

    Job DescriptionAs Quality Assurance and Operations Lead, you'll be a key part of the Quality team who contributes directly to Sellpy's Operations. Your primary responsibility is to ensure quality standards are met across global sites while driving ongoing production improvements in a fast-moving, dynamic setting.Your efforts will be appreciated by many as we...


  • Stockholm, Stockholm, Sweden OHB Sweden AB Full time

    OHB Sweden AB is a leading provider of satellite systems and space solutions. We specialize in developing cutting-edge technology for Earth observation, telecommunications, and scientific research.We are seeking an experienced Quality Assurance Specialist to join our team in Kista. As a key member of the Quality & Product Assurance team, you will be...


  • Stockholm, Stockholm, Sweden Rasulson Consulting AB - Stockholm Full time

    We are looking for a highly skilled Project Quality Assurance Lead to oversee the testing and quality assurance activities for the Beehive project. The ideal candidate will have a strong background in planning and managing the testing of IT systems and processes, as well as in-depth knowledge of various testing methodologies and techniques.About the...


  • Stockholm, Stockholm, Sweden If Skadeforsikring Full time

    We are seeking an experienced Quality Assurance Specialist to join our team at If Skadeforsikring. The ideal candidate will have a strong background in quality assurance of IT systems, with at least 3 years of test management experience.In this role, you will be responsible for creating and maintaining effective working methods and routines to ensure smooth...


  • Stockholm, Stockholm, Sweden Viedoc Technologies AB Full time

    Company OverviewViedoc Technologies AB is a Swedish software company that specializes in designing and developing innovative solutions for clinical research. Our goal is to make a positive impact on people's lives by providing cutting-edge technology that streamlines clinical trials and accelerates access to life-saving treatments.Job DescriptionAs a...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    We are looking for a dedicated Quality Assurance Manager to lead our team at Nordberg Medical in ensuring the highest quality standards in manufacturing processes. As a key member, you will collaborate with cross-functional teams to identify areas for improvement and implement effective solutions.Key ResponsibilitiesCollaborate with maintenance and equipment...


  • Stockholm, Stockholm, Sweden Götgatan Full time

    Sellpy's Vision: Empowering SustainabilityAt Götgatan, we're passionate about improving ad quality and creating a seamless shopping experience that wows our customers. We see a tremendous financial, social, and environmental value in making sure unused items are put to use again.As a Quality Assurance Lead, you'll be a key part of the Quality team who...


  • Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) - Stockholm Full time

    You are a medical doctor with an eye for detail and strive for high-quality deliveries. You are eager to share your clinical knowledge, and enjoy collaborating with clinics to develop machine learning models for clinical use. You excel in maintaining focus and working independently and you enjoy working in a team and actively contributing to projects...


  • Stockholm, Stockholm, Sweden SallyQ AB Full time

    CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers.The Stockholm site is currently looking for a dedicated Senior QA Specialist to support their mission to build a robust quality culture...