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: Computer System Validation Lead
We are looking for a creative and structured Computer System Validation Lead to create system operational Governance documents to secure efficient and compliant management of validated systems.

If you are interested in actively contributing to process improvement and in building and maintaining a compliant quality environment, you may be the person we are looking for.

At Hansa Biopharma we are a small and tight IT team, consisting of three team members. We are seeking a colleague, who thrives in a self-sufficient role and who are passionate about collaboration.

Principal Responsibilities

• Perform IT/QA readiness assessments and create a Validation Strategy
• System Implementation and support – take the role as Validation Lead in implementation and support projects. Planning, executing, supporting and maintaining validation activities
• Plan and lead periodic system reviews
• Support teams performing vendor oversight for clinical studies
• Close cooperation with Quality Assurance Department
  • Support in Vendor Audits (IT Subject Matter Expert to support audits of IT)
  • Assessment of validation status to computerised systems used by Vendors

Professional Qualifications
In order to succeed in this position, you have extensive experience of the above responsibilities to be able to work both independently and collaboratively. We believe you possess:

Ability to identify and solve problems, provide guidance and support. This requires both analytical and creative thinking, as well as the ability to communicate effectively.

Ability to work on multiple smaller projects at the same time and properly prioritize actions.

Brave and trustworthy personality that can facilitate working sessions with various business stakeholders.

The following experience is desirable:

• At least 5 years of experience in IT compliance, computer system validation or similar in the Life Science industry
• Knowledge of GAMP5, FDA CFR 21 Part 11, EU GMP Guide Annex 11
• Cloud Validation – Cloud Control Strategies and Cloud Vendor Management
• Knowledge of M365 environment, especially SharePoint platform
• Knowledge about Quality Assurance

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.

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.

What we offer

• A position in a company that envisions a world where patients with rare immunological diseases lead long and healthy lives.
• The chance to be part of an organisation with a strong desire to make a difference for people.
• An opportunity to build a fully integrated biopharmaceutical company with global outreach.
• An open-minded and welcoming atmosphere. We care about our employees and are immensely proud to have been certified “A Great Place to Work” by Great Place to Work®, a global authority on workplace culture, employee experience and leadership behaviour.
• Friendly, motivated and skilled colleagues with whom you can both laugh and work.

Type of employment

This is a permanent and full-time (40 hours) position.

Hansa Biopharma is based in Lund, Sweden. There is a flexibility to work from home a couple of days per week when possible.

 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.

We would appreciate your application as soon as possible. We will review applications as they are received.

For questions regarding the position and process, please contact the recruiting manager, Johan Oskarsson, Head of IT, johan.oskarsson@hansabiopharma.com.

We look forward to receiving your application – join us and make significant contributions to Hansa Biopharma´s research!

Please note: No external recruitment support is required. Only applications received directly will be considered.