Quality Assurance Specialist - QMS
Would you like to be part of a growing biopharma company?
Hansa Biopharma is a commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with rare immunological conditions.
Our broad therapeutic pipeline based on the company’s proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.
By empowering our people and working in an agile way we move our projects forward with high speed, efficiency and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey.
Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.
Position: Quality Assurance Specialist – QMS
At Hansa Biopharma we are a small QA team seeking a new colleague who thrives in a self-sufficient role and who is passionate about collaboration. If you are interested in actively contributing to supporting the quality mindset and continuing building and maintaining a compliant quality environment, you may be the person we are looking for.
Principal Responsibilities
- Assist with regulatory authority inspections/ internal or external audits by providing administration support
- Assist in preparing, conduct liaison meetings, drop-in sessions supporting Hansa staff
- Manage QA intranet page and QA general email inbox
- Responsible (system admin, superuser) for Hansa QMS (QMapp and Veeva), involved in on/off-boarding
- Prepare systems periodic review reports, manage change controls and support in issue handling
- Plan and prepare for Quality Management System (QMS) quarterly workshops by tracking quality parameters, overseeing and facilitating the development of QA Quality documents and providing overall support for Hansa Quality Document development
- Prepare the Quality Management Review report/presentation
- Responsible for the Physical Archive
- Assist Line and Quality Managers with the planning and organizing GxP Training, ensure the training matrix is updated, create training material as relevant
Professional Qualifications
In order to succeed in this position, you have relevant experience for the above responsibilities to be able to work both independently and collaboratively. We believe that you should possess:
- Life science education, e.g., nurse, pharmacist, lab technician or similar
- Experience in the Pharmaceutical/ Biotech industry, or the health sector
- Good verbal and writing skills, in English
The following experience is desirable:
- Previous experience in a similar role
- Knowledge about Quality Assurance
- At least 3 years of experience in Life Science Industry, knowledge of GxP
Our culture and behaviours
Working at Hansa is more than a job for us and our culture is characterised by pride. Pride in what we do, in the company and in what we have, and will, accomplish for patients around the world. Our culture is supported and enhanced by our behaviours, and above and beyond professional qualifications and experience, we look for the following behaviours in all our future colleagues:
- Self-motivated
- Doer
- Team player
Our people mean everything to us, and so our leaders, in addition to the above, must also be able to evidence the behaviours below:
- Brave
- Empathetic
- Lead-by-example
All these behaviours will be assessed at various stages of the recruitment process.
You as a person
As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone’s unique traits and contributions, and we believe in working together as a team. To foster the best possible organisational match in this role, we hope that you recognise yourself as having the following characteristics:
- Service minded and self-motivated team player with a “can do attitude”
- Systematic approach with the ability to structure work duties and processes that involve others
- Strong communication skills with the ability to explain things in a pedagogical way and help seek solutions
- Social skills with the ability to collaborate with individuals of varying levels of authority and with different perspectives
Hansa is for everyone
At Hansa we aspire to be a truly great place to work. We know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the countries and communities in which we operate and ultimately the patients we exist to serve. Our recruitment policy is simple - hire the best person for the job.
Type of employment
This is a permanent and full-time (40 hours) position. Hansa Biopharma is based in Lund, Sweden. The starting date is February 1 or as agreed upon. We offer flexible working hours and option for hybrid meetings.
The process
Please apply for the position through the following link. Applications should not be sent through any other platform.
Attach your CV and a cover letter in English only. Unfortunately, we are unable to review applications made in other languages.
The last day for applications is November 30th 2024, but we will review applications as they are received and may ultimately close the process earlier.
For questions regarding the position and process, please contact the recruiting manager: Christine Angelin, christine.angelin@hansabiopharma.com.
We look forward to receiving your application – join us and make significant contributions to Hansa Biopharma´s mission!
Please note: No external recruitment support is required. Only applications received directly will be considered.
- Locations
- Lund
- Remote status
- Hybrid Remote
Lund
Quality Assurance Specialist - QMS
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