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QA Director to Antaros Medical
1 month ago
At Antaros Medical, we are pioneering imaging methodologies, such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET), to design and deliver clinical studies for decision making and differentiation in drug development. We currently have around 130 employees working at our offices in Sweden in Mölndal, Uppsala and Lund, and in the US and UK. To deliver on our commitments, we are now looking for aQADirectorto join us. The position is ideally based in our Uppsala office.
As a QA Director, you will be managing QA activities withinAntaros Medical in collaboration with your QA colleagues.
You will ensure Antaros Medical's quality by conducting necessary audits and trainings to guarantee that our operations are compliant, and that clinical trials are performed in accordance with applicable study protocols and in compliance with regulations, guidelines, and our processes. You will be working closely with our QA team, and you will be reporting to the VP QA. The QA team is a part of our compliance function with a mission to provide coordinated and focused compliance support within different areas to the business.
At Antaros Medical you will have a possibility to make a difference, to develop in your role and to contribute to a continued development and improvement of our quality system, our processes and our business.
Asa QADirectorat Antaros Medical, your main responsibilities will be:
- Manage, maintain and proactively improve the Quality System in collaboration with all functional leadsand the QA colleagues to ensure the quality system is aligned with compliance and efficiency needs in the business, changes in regulations, standards and regulations and customer requirements and expectations
- Support the development of new processes, SOPs, templates, and other quality system documents
- QA review and QA approval of quality system documents and cases in our eQMS
- Develop and maintain QA processes and SOPs related to GCP and other relevant regulations, standards and guidelines
- Plan, conduct and report internal audits and vendor audits as detailed in the risk-based audit plan
- Host and manage inspections, sponsor audits, and handle RFIs/vendor assessments
- Support the management of vendors, including qualification of new vendors and regular requalification of existing vendors
- Lead and arrange internal training in relevant areas such as GCP, GDPR, Good Documentation Practice, etc
- Provide day to day general QA support internally
Who you are
We believe that you are a structured and communicative person who will thrive in our dynamic and rapidly developing environment. You are focused on delivering high-quality results and enjoy giving quality-related advice to the organisation, with efficiency in mind. You collaborate very well with others and have a team-oriented approach when engaging with colleagues and clients. And last but not least, you value having fun while doing a meaningful job.
Requirements:
- University degree in Natural Scienceor Medicine
- Several years' experience from the pharmaceutical industry, CROs, or similar business including several years of experience in a QA position
- Extensive understanding of and experience in ICH-GCP
- Knowledge and experience in clinical trials
- Broad understanding of the full drug developmentprocess
- Excellent knowledge of spoken and written English
Advantages:
- Knowledge and experience in imaging in clinical trials
- Thorough understanding of strategic and operational aspects within clinical research and development
- Knowledge and experience in data management/data governance
- Knowledge and experience in computerized systems/IT in the pharmaceutical industry
- Knowledge and experience in data privacy, GDPR and other such regulations
- Knowledge and experience in other relevant guidelines such as GLP and GMP
Are you interested?
We are happy to hear Please submit your application via this link with a short personal letter (in English) and your CV included, no later than March 31 2025. We will contact and interview candidates continuously throughout the recruitment process, so don't wait with your application
For more information about the position, please contact Hans Thunell, VP QA, +46 70617 62 01 or hans.thunell@antarosmedical.com
We only accept applications via our recruitment system, Teamtailor. The recruitment is handled by Antaros Medical.
About Antaros Medical
At Antaros Medical, we combine ground-breaking imaging with profound experience in drug development and deep knowledge of disease mechanisms. We are specialized in cardiorenal & metabolic disease. We have a global network of collaboration partners and customers, including both Big Pharma and Biotechs, and several European collaboration initiatives such as Innovative Medicines Initiative (IMI).
Antaros Medical delivers both small, complex, mechanistic studies as well as large, streamlined multi-center clinical trials utilizing our innovative imaging methods. Our global headquarters and analysis Corelab are based in Sweden. If you want to find out more about our company, please go to our website: www.antarosmedical.com.
Our culture is our people, and our values make us everything that we are. Please feel free to have a look upon our Culture Handbook to get to know us even better: Our culture – Antaros Medical.
