QA Director to Antaros Medical

Would you like to work as a QA Director in a growing company devoted to making a real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere? If this catches your interest, you should continue reading.

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 90 employees working at our offices in Sweden in Mölndal and Uppsala, and we are continuously growing and developing. To deliver on our commitments, we are now looking for a QA Director with broad and deep experience in clinical drug development and GCP to join us. The position is ideally based in our Uppsala or Mölndal office in Sweden but could possibly be placed home-based in Sweden or Europe, in which case regular travel to our Uppsala or Mölndal office would be expected.

As a QA Director, you will be overall responsible for all QA activities within Antaros Medical. You will ensure Antaros Medical´s quality by conducting necessary audits and training to guarantee that our operations comply and run smoothly and that clinical trials and R&D activities are performed in accordance with applicable study protocols and in compliance with laws, regulations, guidelines, and our processes. You will be working closely with our QA team and you will be reporting to the VP IT & QA.

As QA Director at Antaros Medical, your main responsibilities will be:

- Lead the QA function, together with the VP QA & IT
- Manage and maintain the Quality System in collaboration with all functional leads and other QA colleagues
- Support the development of new SOPs, templates, and other quality system documents and perform gap analysis
- Responsible for developing and maintaining all QA SOPs related to GCP
- Plan, conduct and report internal and external audits as detailed in the risk-based audit plan
- Host and manage inspections, Sponsor audits, and desk-top audits until closure
- Assist with information in RFIs/vendor assessments
- Manage complaints and deviations
- Manage and follow-up on the full CAPA process, including CAPA effectiveness
- Vendor assessment, qualification, and risk-based re-assessment
- Lead and arrange internal training in relevant areas such as GCP, GDPR, Quality system, etc
- Provide day to day general QA support internally
- Be up to date with all regulations relevant to our business and inform the organisation of updates


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. 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 Science or Medicine.
- Several years’ experience from clinical trials from the pharmaceutical industry, CROs, or similar business including several years of experience in a QA position
- Extensive understanding of ICH-GCP and other relevant guidelines in relation to both operational aspects as well as quality aspects
- Broad understanding of the full drug development process
- Thorough understanding of strategic and operational aspects within clinical research and development
- Knowledge within imaging in clinical trials is an advantage
- Excellent knowledge of spoken and written Swedish and English


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 August 22th, 2021.

For more information about the position, please contact Johannes Carlsson, VP IT&QA, +46 73 917 86 50 or johannes.carlsson@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 specialised in cardiorenal & metabolic diseases and oncology. 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) and COST. Antaros Medical has delivered small complex, mechanistic studies as well as multi-center clinical trials worldwide utilizing our innovative imaging methods. Our global headquarter and imaging Corelab are based in Sweden.