Quality Assurance
2 weeks ago
BioArctic 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 reaching out to find a new colleague to join a dedicated and highly competent team within the QA department.
As a QA Manager, you will play a crucial role in providing quality oversight of biopharmaceutical development activities outsourced to CMOs and CROs and the supply of investigational medicinal products to clinical trials. You will apply your experience and expertise within QA to ensure GMP compliance and collaborate with colleagues within the QA department and cross-functionally with internal and external stakeholders. This is an excellent opportunity for you to join a great company with an exciting journey ahead. If this sounds interesting to you - Come join us and contribute to our mission of improving the lives of patients with neurodegenerative diseases.
We will interview candidates continuously and welcome your application today
ResponsibilitiesAs a QA Manager, you will report directly to the Senior Director Quality Assurance at BioArctic.
Your main responsibilities will include:
- Assess and approve batch-related documentation such as specifications, batch records, deviations, and change requests.
- Ensure that production and testing of clinical trial materials are conducted according to GMP and the requirements of the IND/IMPD.
- Monitor and maintain the Quality Management System. Review and approve SOPs, periodic review, and supplier re-evaluation.
- Lead and participate in self-inspections and audits of service providers.
- Represent QA in cross-functional project teams.
- Provide support and guidance to the organization in quality issues.
- Perform internal GxP training.
- Contribute to key strategic developments within the QA department.
Key Qualifications for the position include:
- MSc in Pharmacy, Biology, Chemistry, or Engineering.
- Significant experience of working within GMP regulated pharmaceutical industry in the development of biopharmaceuticals.
- Experience from development and manufacturing activities for biopharmaceuticals.
- Several years of experience from a QA organization.
- Experience from managing quality processes such as deviations, CAPAs, change requests, and vendor assurance.
- Understanding of the drug development process and supply chain process.
- QP/RP experience is an advantage.
- Good scientific understanding of biological drugs (products and process).
- In-depth understanding of Quality Systems and GMP legislation and guidelines.
- Good knowledge of national and EU GDP.
- Fluent in Swedish and English.
We are looking for someone with a can-do attitude, strong organizational skills, and a quality-driven mindset. You work well both independently and in team settings and can handle multiple tasks and manage priorities in a timely manner. You enjoy taking responsibility and initiative as well as sharing your expertise with others and have excellent collaboration and communication skills. You are analytical, result-oriented, and can effectively make decisions using risk management and independent judgment. 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 with neurodegenerative diseases and have the skills and experience to excel in this role, we invite you to apply today
About the organisationBioArctic AB (publ) is a research-intensive biopharmaceutical company that, together with its partner Eisai, has developed Leqembi (lecanemab) – the world's first drug to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. In addition to royalties on global sales, BioArctic has the right to commercialize lecanemab in the Nordic market together with Eisai. BioArctic has a broad research portfolio with antibodies against neurodegenerative diseases such as Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. A Phase 2a clinical trial of BioArctic's most advanced antibody for the treatment of Parkinson's disease, exidavnemab, is expected to be initiated in 2024. Several of the projects utilize the company's proprietary BrainTransporter technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit .
```#J-18808-Ljbffr
-
Quality Assurance
2 weeks ago
Stockholm, Stockholm, Sweden Cowboys Unica All Jobs Full timeBioArctic 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 reaching out to find a new colleague to join a dedicated and highly competent team within the QA department. As a QA Manager, you will play a crucial role in providing quality oversight of...
-
Quality Assurance
2 weeks ago
Stockholm, Stockholm, Sweden Qrios Full timeBio Arctic 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 reaching out to find a new colleague to join a dedicated and highly competent team within the QA department.As a QA Manager, you will play a crucial role in providing quality oversight of...
-
Quality Assurance Capability Team leader
2 weeks ago
Stockholm, Stockholm, Sweden Nordea Bank Abp, Filial i Sverige Full timeNordea is a leading bank.Job ID: 23832 We are now looking for a Quality Assurance Capability team leader for Mortgages Technology in the Service Area Mass-Market Products to join our team in Mortgages Technology. As our Capability Team Lead, you'll play a critical role contributing to our technical solutions as well as to our culture and people leadership....
-
Quality Assurance Associate
2 weeks ago
Stockholm, Stockholm, Sweden Karo Healthcare Full timeKaro Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 100 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in...
-
Senior Quality Assurance Manager
2 weeks ago
Stockholm, Stockholm, Sweden EPM Scientific Full timeJoin Our Team as a Senior QA Manager Location: NordicsCompany: Our client is a Top Medical Device OrganisationJob Type: HybridDate: URGENT To be shortlisted ASAPAbout Us:Step into the future of healthcare with a leading medical devices company that's redefining innovation and quality. We're committed to improving patient outcomes and delivering cutting-edge...
-
Quality Assurance Engineer
2 weeks ago
Stockholm, Stockholm, Sweden Hudson Nordic Full timeAnother Snus Factory grundades 2019 med ambitionen att göra saker på ett annat sätt. Vi skapar fantastiska produkter och inspirerande varumärken med tre vägledande principer; att göra saker vi känner oss stolta över, alltid försöka göra det vi tycker är rätt och inte minst att ha kul medan vi gör det.Vi befinner oss i en stor tillväxt där...
-
Stockholm, Stockholm, Sweden Telenor Full timeWho we are Telenor is rapidly heading towards the digital future and we are looking for brilliant people to join our digital transformation journey in Sweden. Do you have an interest in technology and like to challenge the telecom industry and want to create great customer experiences? Do you have a sense of humor and prefer seeking solutions rather...
-
Quality Assurance Engineer
2 weeks ago
Stockholm, Stockholm, Sweden Telness Technologies Full timeTelness Tech is the software company behind Europe's highest-rated mobile virtual network operator (4.9/5 on Trustpilot). Since our launch in 2021, our SaaS service has provided the infrastructure, experience, and expertise that telecom companies need to revolutionize the consumer experience. Our cutting-edge technology removes the complexity and expense...
-
Stockholm, Stockholm, Sweden ITBMed Full timeThe ITB-MED Quality Assurance teamsupport across all areas within ITB-MED from pre-clinical, clinical and also manufacturing and distribution of Investigational Products. We are now looking to hire a new Quality Assurance Manager in Sweden.Job Summary / objective:The Quality Manager is responsible for deployment and management of Quality Assurance electronic...
-
Quality Assurance Designer
2 weeks ago
Stockholm, Stockholm, Sweden ISTITUTO MARANGONI Full timeJoiningFrostbite means becoming part of a team that's not just passionate about gaming, but also about creating the technologies that power some of the most spectacular gaming experiences. We offer a collaborative, inclusive environment where innovation excels, and your contributions have an impact on the visual quality of games enjoyed by millions. Summary...
-
Game quality assurance
3 days ago
Stockholm, Stockholm, Sweden Embark Full timeAs a Game QA at Embark, you are an integral part of a game team's desire to reach the highest quality. You understand the game we are building inside and out and can focus and prioritize the testing and analysis where it matters the most. We believe quality is everyone's responsibility and as a Game QA you will be an enabler for the rest of the team. Example...
-
Quality Engineer
2 weeks ago
Stockholm, Stockholm, Sweden Exeger Full timeExeger is making sustainable energy more accessible for people around the globe with the vision to touch the lives of a billion people by 2030. Our innovative product, Powerfoyle, is the world's only fully customizable solar cell. Our customers, 3M, Urbanista, Adidas Headphones, POC and others, use it to power their most loved products.ABOUT THE POSITIONThe...
-
Quality Assurance Designer
2 weeks ago
Stockholm, Stockholm, Sweden Electronic Arts Full timeResponsibilities Team Support Test tools, report bugs, and provide indispensable support to both software engineers and QA teams to ensure the seamless operation of our rendering technologies. Take primary responsibility for the maintenance and optimization of the screenshot infrastructure. This includes reporting any failures, updating screenshots,...
-
Quality Engineer
2 weeks ago
Stockholm, Stockholm, Sweden Alfa Laval Full timeAlfa Laval is Hiring a Quality EngineerAbout UsAt Alfa Laval, we strive to overcome challenges and drive success for our customers, people, and planet. We believe in the power of curiosity to spark great ideas and progress.Join our team and be part of an inclusive workplace that values diversity and belonging. Contribute to sustainable solutions that address...
-
Sterility assurance specialist
2 weeks ago
Stockholm, Stockholm, Sweden Octapharma Full timeHar du expertkunskap inom mikrobiologi och aseptisk tillverkning? Här är tjänsten för dig som vill arbeta som expert i händelsernas centrum, nära produktionen, mitt i Stockholm. Med familjära värderingar och högt tempo tillverkas bioteknologiskt läkemedel i stor skala dygnet runt på Octapharma. Låter det intressant? Då ska du läsa vidare. Som...
-
Quality and Compliance Engineer
2 weeks ago
Stockholm, Stockholm, Sweden Alfa Laval Full timeAlfa Laval in Tumba is looking for Quality and Compliance EngineerAt Alfa Laval, we always go that extra mile to overcome the toughest challenges. Our driving force is to accelerate success for our customers, people, and planet. You can only achieve that by having dedicated people with a curious mind. Curiosity is the spark behind great ideas. And great...
-
Quality and Compliance Engineer
1 month ago
Stockholm, Stockholm, Sweden Alfa Laval Full timeAlfa Laval in Tumba is looking for Quality and Compliance EngineerAt Alfa Laval, we always go that extra mile to overcome the toughest challenges. Our driving force is to accelerate success for our customers, people, and planet. You can only achieve that by having dedicated people with a curious mind. Curiosity is the spark behind great ideas. And great...
-
Quality and Compliance Engineer
4 weeks ago
Stockholm, Stockholm, Sweden Alfa Laval Full timeAlfa Laval in Tumba is looking for Quality and Compliance EngineerAt Alfa Laval, we always go that extra mile to overcome the toughest challenges. Our driving force is to accelerate success for our customers, people, and planet. You can only achieve that by having dedicated people with a curious mind. Curiosity is the spark behind great ideas. And great...
-
Global Eng. Quality Manager Electronics
2 weeks ago
Stockholm, Stockholm, Sweden Autoliv Full timeAutoliv's primary goal is to Save More Lives. Our products never get a second chance. This is why we can never compromise on quality. We are working to increase vehicle safety by developing seatbelts, airbags and steering wheels and you can be part of our team as Global Engineering Quality Manager . The mission of Global Engineering Quality Manager...
-
Global Eng. Quality Manager Electronics
2 weeks ago
Stockholm, Stockholm, Sweden Autoliv Full timeAutoliv's primary goal is to Save More Lives. Our products never get a second chance. This is why we can never compromise on quality. We are working to increase vehicle safety by developing seatbelts, airbags and steering wheels and you can be part of our team as Global Engineering Quality Manager.The mission of Global Engineering Quality Managerencompasses...
