About us

Hansa Biopharma is a fast-growing, commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with acute or complex immune disorders.

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 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 summary

We are looking for a CMC Quality Manager with extensive experience in quality work related to maintaining GMP compliance for commercial product(s) as well as development and GMP production of novel biologicals.

You enjoy engaging with CMC activities and have broad experience with biological products and want to be part of the quality assurance of products used to treat severe IgG-driven diseases, improving patient' health and well-being.

Hansa Biopharma has an agile project-oriented workflow, and the skills and initiatives of each team member are vital for advancing projects. You will report to the Head of Early Stage CMC Development and Manufacturing at Hansa Biopharma.

Key tasks and responsibilities

• Provide support to the CMC Department in Good Manufacturing Practices (GMPs) with significant operational and quality experience.
• Provide independent oversight and compliance direction with authority for CMC Quality and product disposition, including CDMO’s and CMOs.
• Drive process and product quality through CMC quality systems, ensuring adequate supplier oversight/surveillance.
• Approve Protocol and Reports, Master Batch Records and Executed Batch Records at the CDMO and the CROs for Filling.
• Participate in contracts with external parties such as CMOs, CROs, and consultants.
• Provide strategic planning input and continual improvement measures focused on records processes, reporting/escalating critical quality issues.
• Document and initiate change control, perform quality investigation reports in Hansa´s quality management system.
• Conduct risk mitigation in the compilation of records and associated review activities, ensuring a compliant culture of quality.
• Manage, maintain, and continuously improve the batch review process as a facilitator for Quality Assurance in product teams.
• Identify, develop, and implement key performance metrics associated with the post-manufacture assembly of records, including CMO performance metrics relating to quality and error reduction. 
• Encourage an environment for ‘Quality Right First Time’ by building in efficiencies as necessary from a systematic and compliance perspective.
• Perform additional quality-related duties as assigned by Head of Early Stage CMC Development and Manufacturing.

Education and experience requirements

To succeed in this position, we believe that you should have the following background and experience:

• University degree (M.Sc. or equivalent) in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, Engineering, or other relevant life science field.
• More than 5 years of experience in quality assurance in drug development and commercial manufacturing in the biopharmaceutical industry.
• Solid GMP-regulated experience working in GMP quality systems and with drug substances and drug products; clinical and commercial experience in a GMP environment is required.
• Experience interacting with the FDA, EMA and other global health authorities.
• Excellent verbal and written communication and presentation skills in English, preferably also in Swedish.

About you

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:

• Comfortable in taking responsibility and enjoy taking initiative.
• Ability to drive collaboration with vendors, and external and internal parties.
• Creative mind with ability in solution-oriented analytical thinking.
• Thriving in fast moving project environment, enjoy challenging tasks with tight deadlines.
• Comfortable in small company setup and work outside your expertise area when needed.

Our culture and values

Working at Hansa is more than a job for us, and our culture is characterised by pride — pride in what we do, in our company, and in what we have achieved and will accomplish for patients around the world.

Our culture is built on our core values: Accountability, Courage, Integrity, and Pioneering. These values guide how we work, collaborate, and make decisions every day.

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.

Reasons to join the Hansa Team

• Collaborative and science-driven culture that values innovation, impact, and continuous learning.
• Work at the cutting edge of biologics development, contributing to life-changing therapies.
• A position in a company that envisions life changing outcomes for patients with acute or serious immune mediated conditions.
• The chance to be part of an innovative R&D-driven organization 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. Friendly, motivated and skilled colleagues with whom you can both laugh and work.

Type of employment and location

This is a permanent, full-time (40-hours) position based in Lund, Sweden. The role requires regular on-site presence, with an expectation of four days per week in the office.

Start date as soon as 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.

The process is ongoing and we will review applications as they are received.

For questions regarding the position and process, please contact the recruiting manager: Amelia Hofgren, Head of Early stage CMC development and Manufacturing.

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.