
Clinical Quality Assurance Director
1 day ago
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 guidance of supplier management teams.
Key Responsibilities
- Act as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.
- Maintain oversight of quality topics for Sobi IMPs across markets.
- Continuously improve work processes related to quality and compliance of IMPs.
- 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.
Required Skills and Qualifications
- Bachelor's degree or equivalent education/degree in life sciences.
- Solid understanding of the GMP & GDP and GCP requirements in support of IMP study.
- 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.
Benefits
- Emphasis on work/life balance.
- Collaborative and team-oriented environment.
- Opportunities for professional growth.
- Diversity and Inclusion.
- Competitive compensation for your work.
- Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments.
-
Quality Assurance Lead Clinical Trials
1 day ago
Stockholm, Stockholm, Sweden Sobi, Inc Full timeWe 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)...
-
Quality Assurance and Compliance Expert
3 days ago
Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeQuality 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...
-
Director of Pharmaceutical Quality Assurance
3 days ago
Stockholm, Stockholm, Sweden Sobi, Inc Full timeRole Summary:We are seeking a highly skilled leader to fill the position of Director of Pharmaceutical Quality Assurance. As an experienced expert in analytical science and technology, you will be responsible for overseeing a team of talented scientists, driving analytical excellence across various activities related to commercial product supply.The...
-
Quality Assurance Specialist
6 days ago
Stockholm, Stockholm, Sweden OHB Sweden AB Full timeOHB 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...
-
Quality Assurance Expert
4 days ago
Stockholm, Stockholm, Sweden Deploja AB Full timeKey Responsibilities:We are seeking an experienced Quality Assurance Expert to join our IT-project management team at Deploja AB. In this role, you will be responsible for ensuring that all software applications meet the required standards of quality, reliability, and performance.Your primary focus will be on developing and implementing comprehensive testing...
-
Quality Assurance Specialist
3 hours ago
Stockholm, Stockholm, Sweden If Skadeforsikring Full timeWe 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...
-
Quality Assurance Professional
5 days ago
Stockholm, Stockholm, Sweden Deploja AB Full timeWe are looking for a highly skilled Quality Assurance Professional to join our team at Deploja AB. As a key member of our quality assurance team, you will be responsible for developing and implementing automated test scripts to validate the functionality, performance, and system integration of our software.Key Requirements:Proven experience in software...
-
Quality Assurance Specialist
6 days ago
Stockholm, Stockholm, Sweden SQA Services Full timeSQA Services is seeking a highly skilled Quality Assurance Specialist to join our global quality auditing team. As a Senior Quality Auditor, you will play a critical role in assuring quality in the supply chains of our clients in life sciences.This position offers an exciting opportunity to work closely with SQA's operations center to coordinate, prepare,...
-
Quality Assurance Specialist
1 day ago
Stockholm, Stockholm, Sweden SHL Group Full timeThe Role:Quality Assurance SpecialistWe are seeking a Quality Assurance Specialist to join our team at SHL Medical. The ideal candidate will have 3-5+ years of relevant work experience, with a strong understanding of regulations and ISO standards.Main Responsibilities:Support the project team in conducting risk management activities and establishing a risk...
-
Software Quality Assurance Specialist
4 days ago
Stockholm, Stockholm, Sweden Terna Systems AB Full timeTerna Systems AB is a pioneering company in the development of innovative software solutions for various industries. We are seeking a talented Unity Quality Assurance and Support Engineer to join our team.As a Unity Quality Assurance and Support Engineer, you will be responsible for ensuring the quality and integrity of our applications. Your key...
-
Global Quality Director
4 days ago
Stockholm, Stockholm, Sweden Level Recruitment AB Full timeGlobal Quality Director at RustaWe are seeking a seasoned Quality Director to lead our global quality team and drive excellence in product development. As a key member of the sourcing organization, you will be responsible for ensuring that our products meet the highest standards of safety, durability, and functionality.The ideal candidate will have a strong...
-
Quality Assurance Professional
3 days ago
Stockholm, Stockholm, Sweden Anocca Full timeWe are looking for a Quality Assurance Professional to join our QC team at Anocca. As a member of this dynamic group, you will play a crucial role in ensuring the highest standards of quality and compliance in the analysis and release of ATMP products.The ideal candidate will have experience working according to GMP, with a strong background in quality...
-
Quality Assurance Lead
4 days ago
Stockholm, Stockholm, Sweden RPS Softwares AB Full timeAre 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...
-
Quality Assurance Manager
3 days ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timeWe 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...
-
Quality Assurance Specialist
3 days ago
Stockholm, Stockholm, Sweden Götgatan Full timeSellpy'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...
-
Software Quality Assurance Engineer
18 hours ago
Stockholm, Stockholm, Sweden efficy Full timeAt Efficy, we are dedicated to delivering high-quality software solutions that meet the evolving needs of our customers.We are seeking a skilled Software Quality Assurance Engineer to join our team and contribute to the development of our innovative products.The ideal candidate will have a proven track record of ensuring the quality and reliability of...
-
GMP Compliance Specialist
1 day ago
Stockholm, Stockholm, Sweden Sobi, Inc Full timeAbout 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...
-
Senior Quality Assurance Specialist
5 days ago
Stockholm, Stockholm, Sweden SallyQ AB Full timeCareDx, 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...
-
Quality Assurance Engineer
4 days ago
Stockholm, Stockholm, Sweden RPS Softwares AB Full timeWe are seeking a skilled Quality Assurance Engineer to develop and maintain automated test scripts ensuring high-quality software delivery in an agile environment. As a key member of our team, you will work closely with developers, system managers, and stakeholders.The ideal candidate will have strong experience with test automation frameworks (Selenium,...
-
Quality Assurance Lead
5 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeWe 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...