QA Manager Audits and 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: QA Manager Audits and QMS

At Hansa Biopharma we are a QA team of six people, now seeking to replace our colleague who is transitioning into retirement after many successful years with the company.  In this role you will have a range of QA Manager responsibilities with focus on GxP supplier oversight including auditing external vendors and performing and support internal audits. This role entails a lot of cross-collaboration both within the company and with external stakeholders. This position also has the role of Deputy Responsible Person.

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

Contribute to QA strategy and overall planning by working with department managers and process owners to develop QA strategies.

• Provide leadership and expertise within Quality Assurance throughout the company
• Monitor regulations and guidelines that have an impact on Hansa Biopharma’s business

Manage employee training and continuous learning of quality mindfulness including, but not limited to, good documentation practices, issue escalation, and process improvement

• Quality responsible for audits (e.g annual audit plans and reports) within GMP, GDP, GVP, GCP and GcLP and continually monitoring performance
• Plan, coordinate and execute internal and external audits, and prepare for and coordinate audit/inspections of Hansa Biopharma by external parties and Health authorities
• Assess and qualify potential external GxP service providers
• Monitor GxP services performed by external parties.
• Monitor, assess, and manage/investigate reported issues
• Establish and maintain quality procedures within area of responsibility and ensure implementation in accordance with applicable laws, regulations and guidelines in compliance with Hansa´ procedures and processes.
• Review service agreements/Technical Quality Agreements for external GxP work.

Gather and present quality metrics e.g audit/inspection KPI for key stakeholders including periodic management reviews

Drive company-wide, departmental, and/or focused process improvement projects.

QMS Job Roles

• QA Manager
• QMS Process Manager (Deputy)
• GDP Responsible Person (RP) (Deputy)

Professional Qualifications

• Minimum 15 years' experience from pharmaceutical industry within quality, manufacturing, product development and/or regulatory affairs

• Pharmaceutical and business understanding including in-depth knowledge about regulatory and GxP requirements
• Strong experience of GxP auditing with focus on GMP/GDP (qualified auditor)
• Strong experience of Quality oversight processes of GxP suppliers
• Strong experience from building and managing global GxP QMS structures
• Experience from working with improving business practices/working procedures related to GxP
• Experience from implementation and governance of eQMS
• Experienced in working with high impact stakeholders, e.g. authorities, strategic business partners
• Experience from setting up and working with performance management, KPIs, including the management cycle
• Experience from working in an international organisation and across borders and with different cultures
• Fluent in Swedish and English

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 team members?, 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:

1. Strong collaboration skills with the ability to listen as well as influence others by contributing with your expertise and contributing toward finding solutions.
2. Ability to manage your work in a structured way.
3. Excellent communication skills, communicate clearly in a pedagogical way.

Type of employment

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

Hansa Biopharma is based in Lund, Sweden and we offer flexible working hours.

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 1 April 2025.

For questions regarding the position and process, please contact the recruiting manager Anna Löfgren, anna.lofgren@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.