Quality & Compliance Manager in IT

Would you like to work with IT and Computerised Systems as a Quality & Compliance Manager, in a growing company devoted to make 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 sounds interesting, 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 are specialized in cardiometabolic diseases (including NAFLD/NASH and chronic kidney disease) and oncology. We have established ourselves as a strategic development partner to the pharmaceutical industry. We combine ground-breaking imaging with profound experience in drug development and deep knowledge of disease mechanisms. Our projects cover clinical trials in all stages of drug development, and we work both with small biotech companies and global big pharma companies. We currently have around 100 employees working at our offices in Mölndal, Uppsala and Malmö.

As Quality & Compliance Manager in IT/Computerised Systems, you will provide QA oversight and support the implementation, development,risk management, validation, management and use of compliance related electronic systems within the business and in the clinical studies in accordance with ICH-GCP, EU/Annex 11, GAMP and FDA/21 CFR part 11, and Data Integrity GxP requirements.

You will also support the internal departments in developing and maintaining SOPs related to electronic systems as well as work with validation, vendor qualification and compliance. You will be working closely with our QA team; VP IT & QA, COO and Head of Software. The position can be based in either Uppsala, Mölndal or Malmö.

As Quality & Compliance Manager in IT/Computerised Systems at Antaros Medical, your main responsibilities will be:

- Ensure that computerized systems are implemented, developed, validated and managed in accordance with the defined processes, SOPs, standards and policies
- Review and approve documents and solutions based on defined processes, SOPs, standards and policies for computerised systemsSupport the development of new and update of existing SOPs, templates and other quality system documents for computerised systems
- Assist in inspections and customer audits and with information in RFIs/vendor assessments
- Advice organisation in data integrity and computerised system related questions concerning compliance with defined SOPs, standards and policies
- Lead and support vendor assessment, qualification and risk-based re-assessment of vendors delivering computerised systems/software
- Take part in validation and release of systems as per internal processes
- Take part in validation of data lifecycle in clinical studies
- Take part in changes of systems as per internal processes
- Perform activities related to the maintenance of the validated state for computerised systems as per internal processes
- Support the clinical study teams in questions related to computerized systems and data integrity/data lifecycles in specific studies
- Lead and provide support for CAPAs, issues and system non-conformities for computerised systems
- Identify suggestions for improvements and lead improvement projects related to processes, SOPs, standards and policies for computerised systems


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. Last but not least, you value having fun while doing a meaningful job.

Requirements

- University degree in Natural Science, Engineering/IT or Medicine.
- Experience within the pharmaceutical-, biotech- or medtech industry as an IT Subject Matter Expert, within quality assurance (QA) working with quality or computerised system
- Excellent knowledge of spoken and written English


Meritorious

- Experience from clinical trials from the pharmaceutical-, biotech- or medtech industry, CROs, or similar business
- Understanding of ICH-GCP, EU/Annex 11, GAMP and FDA/21 CFR part 11 and Data Integrity GxP requirements, and other relevant guidelines concerning both operational aspects as well as quality aspects


More information

For more information about the position, please contact Johannes Carlsson, VP IT & QA
46 73 9178650

Please submit your application via this link with a short personal letter in English and your CV included, no later than January 16th, 2022.