Clinical Quality Assurance Lead

3 days ago


Stockholm, Stockholm, Sweden TN Sweden Full time
Role Overview

This senior-level position reports directly to the Head of Global QA and is responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) across various markets. The ideal candidate will have extensive experience in pharmaceutical or biotech industries, with a strong understanding of GMP, GDP, and GCP regulations.

Main Responsibilities:

  • Lead supplier management teams to maintain quality oversight of IMPs.
  • Act as primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.
  • 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.
  • Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
  • Work cross-functionally with R&D, GCP/GVP QA, QA Supplier Managers, and Product Quality Leads to address and escalate IMP quality issues.

About You

You are a seasoned professional with a proven track record in quality assurance, particularly in the pharmaceutical or biotech sectors. Your expertise includes a deep understanding of regulatory requirements, excellent leadership skills, and the ability to foster open communication among cross-functional teams.



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

    Clinical Quality Assurance SpecialistWe are seeking a highly skilled Clinical Quality Assurance Specialist to join our team at Sobi. As a Clinical Quality Assurance Specialist, you will play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams.Key...


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

    Job Description:Sobi is a global biopharmaceutical company dedicated to transforming the lives of people with rare and debilitating diseases. We are seeking an experienced Clinical Quality Assurance Manager to join our team.Key Responsibilities:Act as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit...


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

    Quality Assurance Lead - Pharmaceutical ProductsAt Sobi, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo. We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.As the Quality...


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

    Job Overview:We are seeking an experienced Clinical Quality Assurance Manager to join our team at Sobi. As a key member of our quality assurance department, you will play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams.Responsibilities:Act as...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Clinical Quality Assurance Manager Role SummaryThe successful candidate will lead the development, implementation, and maintenance of quality systems to ensure the compliance of Investigational Medicinal Products (IMPs) with regulatory requirements. This includes managing supplier relationships, conducting audits and assessments, and coordinating corrective...


  • Stockholm, Stockholm, Sweden DevsData Tech Talent LLC - IT Recruitment Full time

    Job Summary:We are seeking a Quality Assurance Lead to manage the defect/test management process, tracking resolution from start to finish in the Software Development Life Cycle (SDLC).Triaging defects, assigning to action owners, and accelerating progress are key responsibilities for this role.Key Responsibilities:Manage the defect/test management process,...


  • Stockholm, Stockholm, Sweden Dynavox Group AB Full time

    Dynavox Group AB is a global leader in assistive communication technology, empowering people with disabilities to express themselves and connect with the world. We're committed to innovation, customer-centricity, and excellence in everything we do.We're seeking a talented Quality Assurance Professional to join our Product & Development team in Stockholm. In...


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

    Job Summary:The Clinical Quality Assurance Manager will be responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through their leadership and guidance of supplier management teams. The successful candidate will have a strong background in quality assurance and a solid understanding of regulatory requirements.Key...

  • Operations Lead

    7 days ago


    Stockholm, Stockholm, Sweden TN Sweden Full time

    About Our ClientOur client is a leading company in the biotech industry, seeking an experienced Clinical Operations Manager to join their team. As a key member of the client's operations team, you will be responsible for overseeing the delivery of clinical projects, ensuring timely completion, and maintaining high-quality results.Key Responsibilities* Manage...


  • Stockholm, Stockholm, Sweden Northvolt Full time

    Job DescriptionWe are seeking an experienced professional to lead and coordinate supplier management activities for Northvolt's suppliers.Key Responsibilities:Lead and coordinate supplier selection, industrialization, and quality assurance processes.Execute supplier audits, specifically QMS audits and process audits.Advise category managers on nomination...


  • Stockholm, Stockholm, Sweden Nordea Bank Norge ASA Full time

    About the Role">As a key member of our IT team, you will play a crucial role in ensuring the overall quality of our IT deliveries. Your expertise in test management tools and experience in managing functional- and non-functional testing will be invaluable assets to our organization.Responsibilities">Secure the overall quality of IT deliveriesImplement and...


  • Stockholm, Stockholm, Sweden Dynavox Group Full time

    Tobii Dynavox is seeking a highly motivated Quality Assurance Engineer to join our Product & Development team in Stockholm. In this role, you will be responsible for defining, maintaining and executing on test suites, ensuring that our software meets the highest standards of quality.Key Responsibilities:Collaborate with stakeholders to define and maintain...


  • Stockholm, Stockholm, Sweden Qbtech - Stockholm Full time

    The RoleYou will join a cross-functional team using agile methodology to develop medical software applications as a Senior Test and Verification Engineer at Qbtech - Stockholm.This role supports continuous integration, ensuring our products meet requirements and design standards through quality assurance.We operate in an international environment with...


  • Stockholm, Stockholm, Sweden Alfa Laval Technologies AB Full time

    About the OpportunityWe are seeking a Quality Assurance Engineer to join our team at Alfa Laval Technologies AB. As a Quality Assurance Engineer, you will be responsible for ensuring that our products meet the highest quality standards. You will work closely with cross-functional teams to identify and implement improvements, and develop and maintain our...


  • Stockholm, Stockholm, Sweden CabinAir Full time

    About CabinAirWe are a pioneering company dedicated to delivering innovative air purification solutions for the automotive industry.Our mission is to improve the health, safety, and wellbeing of drivers and passengers by providing cutting-edge technology that exceeds industry standards.Job Description:The Quality Engineer will be responsible for leading and...


  • Stockholm, Stockholm, Sweden Embark Full time

    Quality Assurance ExpertWe are seeking a skilled Quality Assurance Expert to join our team at Embark. In this role, you will play a critical part in ensuring the highest quality games reach our players.Key Responsibilities:Collaborate with the development team to identify and address quality issues.Develop and maintain test cases and procedures to ensure...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are looking for a highly skilled Cybersecurity Risk & Quality Assurance Manager to join our team at TN Sweden. As a consultant, you will work closely with our clients to ensure comprehensive cybersecurity risk management and quality assurance processes.Your primary responsibilities will include integrating cybersecurity risk management into the Enterprise...


  • Stockholm, Stockholm, Sweden Igbaffiliate Full time

    Igbaffiliate is looking for a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and reliability of our web applications.Responsibilities:Verify implemented functionality and tasksCreate and maintain test documentation (Test Cases, Bug Reports, Checklists)Communicate with...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Job DescriptionWe are seeking an experienced Senior Clinical Quality Manager to join our team in Stockholm, Sweden or Basel, Switzerland. In this role, you will be responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) across various markets.Key Qualifications:Bachelor's degree or equivalent education/degree in life...


  • Stockholm, Stockholm, Sweden Dynavox Group AB Full time

    Dynavox Group AB is a global leader in assistive communication technology, empowering people with disabilities to express themselves and connect with the world. We're committed to innovation, customer-centricity, and excellence in everything we do.We're seeking a talented Test Automation Specialist to join our Product & Development team in Stockholm. In this...