Senior Quality Assurance Manager, Xbrane

Publiceringsdatum: 2025-06-09

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Jobbannons

Xbrane Biopharma AB is a pioneering Swedish biotech company dedicated to delivering high-quality biosimilar drugs—affordable alternatives to existing biologic therapies. We have an exciting opportunity for you to join Xbrane Biopharma as Senior Quality Assurance Manager. Xbrane is actively exploring strategic opportunities for expansion, and as part of our team, you’ll play a role in shaping how we grow our presence in the global biosimilar market and venture into new areas.

About the Role

Xbrane Biopharma is looking for a Senior Quality Assurance Manager. You will have the opportunity to join an innovative and growing team within the development and commercialization of Biosimilars. In this role, you will play a key part in ensuring the continued high quality of our commercial manufacturing processes, conducted at outsourced manufacturing sites. You will contribute to the maintenance and development of Xbrane’s internal Quality Management System, working closely with a dedicated QA team. You will also work with internal release of intermediate products for final release by QP at Xbrane and support tech-transfer activities related to Xbranes Biosimilars portfolio.

As part of your daily work at Xbrane Biopharma, you will contribute to building long-term quality by staying up to date within the field of Quality Assurance and GxP, while actively sharing knowledge and fostering the development of a strong quality culture across the organization. For the right candidate there will be a possibility to become a Qualified Person at Xbrane.

Key Responsibilities

Build quality into our company by:

• Implementing and maintaining a Quality System that addresses the critical role quality and regulatory compliance plays in Xbrane Biopharma’s development.
• Collaborating with all Xbrane’s departments to ensure that quality standards and GxP compliance are met and maintained.
• Support commercial manufacturing activities of commercial Biosimilar for approved markets including batch review and release.
• Maintain and take ownership for Quality Processes.
• Coordinate quality management reviews and quality metrics exercises together with the Xbrane QA team.

Build quality externally by

• Establishing strong relationships and collaboration with internal and external partners.
• Establishing and maintaining Quality oversight of external partners .
• Supporting inspections from authorities and other external parties.
• Review and approve quality related documentation such as Change Controls, Deviation Reports and CAPAs.
• Support tech transfer activities related to commercial and development biosimilars.

Your Profile:

As our new colleague in the QA department, you will be the next important piece of the puzzle making Xbrane Biopharma ready for the future. In the role of Senior Quality Assurance Manager, you will take part in a wide range of responsibilities across the QA field—spanning development, clinical trials, and commercial manufacturing of biosimilars. We are looking for a candidate who meets the following qualifications:

• A university degree in life sciences, e.g. pharmacist, biotechnology, chemistry or similar (minimum 240 hp).
• Extensive experience from working with Quality Assurance within the pharmaceutical industry.
• A strong team focus combined with proactiveness, creating an efficient and fun environment.
• Excellent verbal and written communication skills in English.
• Strong interpersonal skills and the ability to collaborate with a variety of business areas.
• Ability to take own initiative and proactively resolve issues together with a cross functional team at Xbrane together with our suppliers.

Additional advantages:

• Extensive knowledge of US and EU GxP requirements and industry practices.
• Experience working with one or more of Aseptic filling, Biotechnological manufacturing, external manufacturing, tech transfer and/or Quality Control.

To succeed in this role, you bring a positive mindset, a collaborative spirit, and a willingness to embrace a no-blame culture. You are flexible when priorities shift and approach challenges with a solution-focused attitude. The selection will be based on both your qualifications and personal suitability.

Why choose Xbrane Biopharma?

Xbrane Biopharma is a values-driven and certified Great Place to Work® that offers opportunities for professional growth, influence, and development in a people-focused environment. If you have a can-do attitude and on top of that share our values; — Make it happen, Beat yesterday, Nothing is Impossible, and We win as one, you will thrive together with us. We believe that when you thrive, so does our impact. That’s why we offer a benefits package designed to support your well-being, both in and outside of work.

Interested?

In this recruitment, Xbrane Biopharma is collaborating with Mpya Sci & Tech. Please submit your application at www.mpyascitech.com no later than the 10th of August. We are conducting an ongoing selection process, so don't delay your application, as the position may be filled before the final application date. Questions? Please contact Halala Pirooti at +46(0)73 148 98 65 or halala.pirooti@mpyascitech.com or Britta Granath britta.granath@mpyascitech.com.

Xbrane Biopharma is a Swedish biotechnology company that develops and manufactures biosimilars. We’re proud to be a Great Place to Work® certified company, where innovation, collaboration, and an entrepreneurial mindset are at the heart of everything we do. Our vision and business concept are closely aligned with global sustainability and contribute to achieving the UN Sustainable Development Goals No. 3 – Good Health and Well-being, and No. 10 – Reduced Inequalities. Xbrane’s headquarters are located at the vibrant Solna Campus just outside Stockholm, offering a collaborative and inspiring work environment. Please visit www.xbrane.com for more information.