Career Opportunity at Antaros Medical AB: Director Quality Assurance
Antaros Medical AB
Would you like to work in an innovative biotech company characterized by an entrepreneurial and inspiring spirit? A company, where you would be valued for your competence, ideas and creativity. A place where relations and trust are keys to success and where we all value having fun while doing a meaningful job. If this sounds interesting, we may have the perfect offer for you.
Antaros Medical is 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. The company is specialised in cardiometabolic diseases (including NAFLD/NASH and chronic kidney disease) and oncology. The company has a global network of partners and customers, including both large and small drug development companies, and is a partner in several European research consortia, such as the Innovative Medicine Initiative (IMI) and COST. The company is based in the BioVentureHub in Mölndal and in Uppsala Science Park, Sweden.
Antaros Medical experience a steady growth and currently have around 50 people employed. To deliver on our commitments, we are now looking for people with both broad and deep experience in clinical drug development and GCP.
As Director Quality Assurance, you will be overall responsible for all QA activities within Antaros Medical. You will ensure Antaros Medical´s quality by conducting necessary audits and trainings to guarantee that our operations is in compliance and runs 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 have excellent knowledge of ICH-GCP, GDPR and other current and relevant regulations and standards and possess a thorough understanding of strategic and operational aspects within clinical research and development. At present, the QA Department consists of this position only, which means that the work is varied and that you must be both operational and communicative while at the same time having overall control over the company's quality. The position can be located in our offices in Mölndal or Uppsala and reports to the CEO.
As Director Quality Assurance at Antaros Medical, your main responsibilities will be:
- Manage and maintain the Quality System in collaboration with all functional leads Support the development of new SOPs, templates and other quality system documents and perform gap analysis
- Responsible for developing and maintaining all QA SOPs
- Plan, conduct and report internal and external audits as detailed in the risk based audit plan
- Host and manage inspections, external audits and desk-top audits until closure and assist with information in RFIs/vendor assessments
- Manage complaints and deviations until closure
- Manage the 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 organization of updates
- Summarize and communicate quality metrics to the Management team and/or board on at least a yearly basis
- Data Protection Officer
- University degree in Natural Science or Medicine. PhD is an advantage.
- Several years’ experience from clinical trials from the pharmaceutical industry, CROs or similar business including several years of experience as a QA Manager with overall quality responsibility
- 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
- Knowledge within software development and validation is an advantage
- Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
- Demonstrated leadership and collaboration skills as well as a team-oriented approach to engage with colleagues and clients
- Excellent knowledge of spoken and written Swedish and English
For more information about the position, please contact Caroline Engvall, Chief Operating Officer +46 733 319 112.
Please submit your application via this link with a short personal letter and your CV included, no later than December 31, 2019.