Quality Assurance, Antaros Medical
Would you like to be responsible for QA in a growing company devoted to making a real difference in drug development through ground-breaking imaging? How about working in a leadership role where you can impact the organisation and the growth journey we are on? 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 value competence and development as well as ideas and solutions. Relations and trust are keys to success, and it is equally important for us to have fun while doing a meaningful job. We have currently around 120 employees working at our offices in Sweden in Gothenburg, Uppsala and Malmö, as well as a newly established subsidiary in the US, and we are continuously growing and developing.
To deliver on our commitments, we are now looking for a VP QA with broad and deep experience of quality assurance in clinical drug development and in management to join us. The position is ideally based in our Uppsala, Mölndal or Malmö office in Sweden but could possibly be placed home-based in Sweden as well, in which case regular travel to our Uppsala or Mölndal office would be expected.
What would you be responsible for as a VP QA at Antaros Medical?
The position is a senior management role where you will be responsible for the QA Department, today consisting of a team of five employees/consultants. As VP QA, you will be responsible for the department and its processes and activities, where you will actively implement Antaros Medical’s strategy within the department and work closely with the operational departments and the COO.
You will ensure Antaros Medical’s quality by overseeing and conducting necessary audits and trainings 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.
Your main responsibilities:
- Manage and develop the QA function, including complete responsibility of QA process development
- Provide leadership and direction to the QA Department including mentoring, coaching and development of the staff as well as recruitment and introduction of new staff
- Leading the day-to-day QA operations ensuring challenges and changes are addressed, activities are well-planned, and priorities are clear
- Improve efficiency, plan resources, and develop short-term as well as long-term strategies for the QA Department, that align with overall company development, strategy and goals
- Overall responsible for the Antaros Quality system in general and all QA SOPs
- Oversee the development and maintenance of the internal audit plan and ensure audits are performed and closed
- Perform QA activities according to Antaros QS SOPs including but not limited to audits, answering RFIs, SOP review, handle deviations, and vendor qualifications
- Ensure Antaros is up to date with all regulations relevant to our business and inform the organisation of updates
Other responsibilities include:
- Support the development of new SOPs, templates, and other quality system documents and perform gap analysis
- Ensure Antaros staff is well-trained in relevant areas such as GCP, GDPR, Quality system, etc
- Provide day to day general QA support internally
Who are we looking for?
We believe that you are a committed, organized and flexible leader who enjoys and embraces change in which you likewise create structure, and will naturally thrive in our dynamic and rapidly developing environment. You have demonstrated leadership- and collaboration skills as well as a team-oriented approach to engage with colleagues and clients. You enjoy giving quality-related advice to the organisation.
Further, you have the ability to handle multiple tasks and projects to meet deadlines while delivering high quality work. Drive and commitment together with assertiveness in decision making are definite features we value in your character, and we can see that it gives you energy working with continuous improvement initiatives. And last but not least, you value having fun while doing a meaningful job.
- University degree in Natural Science, Medicine or similar field.
- Several years’ experience in managing a QA group or department
- 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 from a QA perspective
- Thorough understanding of strategic and operational aspects within clinical research and development
- Experience from internal and external audits
- Excellent knowledge of spoken and written Swedish and English
Knowledge within imaging in clinical trials is perceived as an advantage for the role but not required, as well is knowledge in GLP, GMP and/or GDP.
Are you interested?
Wonderful to hear! Please submit your application via the link with a short personal letter (in English) and your CV included, no later than November 27th, 2022.
Please attach degree certificates from higher level education(s) together with your application.
For more information about the position, please contact Johannes Hulthe, CEO Antaros Medical, on email@example.com
We only accept applications via our recruitment system, Teamtailor. The recruitment is handled by Antaros Medical. We kindly decline any contact from recruitment- or staffing firms.
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, and we have recently opened a subsidiary in the US.
You are very welcomed to visit our website to learn more about our company: 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 more: Our culture – Antaros Medical