About the Job

As a Sterility Team Leader, you will play a key role in ensuring the microbiological quality and compliance of our pharmaceutical products throughout their lifecycle. You will lead a team of microbiology specialists responsible for sterility testing activities supporting both API and FDF products across multiple Xellia sites. You will be responsible for leading and coordinating daily laboratory activities, ensuring GMP compliance, timely delivery of test results, and driving investigations, deviations, and continuous improvement initiatives. You will work closely with QA, manufacturing sites, and global stakeholders to ensure reliable and timely microbiological support for product release and stability programs.

Main Responsibilities

• Participation related to regulatory inspections and corporate audits, including audit/inspection readiness, communications, response handling.
• Participation in local and global projects.
• Strong leadership skills: Lead the team, review and delegate the tasks, report the results to the manager.
• Hold the team together and help them to improve and shine.
• Creation of weekly and monthly reports about the organization performance.
• Training of the team members and foster continuous improvement and develop solutions to address issues, improve processes and quality metrics.
• Participation in prepariation work and review of the microbiological methods (routine /transfer).
• Supervise & review of microbiological tests: (Total viable count: TVC, Specified Microorganism Test: SMT; Most Probable number: MPN, Bacterial Endotoxin test).
• Reading and evaluating & reporting the results of microbiological tests.
• Drive projects to completion by proposing solutions, gathering feedback from stakeholders, identifying areas which need escalation and sharing lessons learned.
• Write and revise SOPs as required for this job function. Circulate for review, incorporate/address reviewer comments appropriately and ensure timely approval.
• Escalate issues or potential Quality events in a timely manner.
• Maintain and continuously develop knowledge of global GxP regulations and guidelines. This knowledge should be used to make quality decisions (Ph. Eur, USP, JP).
• Satisfactorily completes all cGMP corporate and safety training in conformance with Xellia requirements.

What We Expect

• BSc in relevant scientific field and a minimum of 3 years of cGMP experience.
• Minimum 3 years of experience participating member of a routine Pharma QC laboratory.
• Excellent written and oral communication skills both in English and Hungarian.
• Excellent analytical abilities and problem solving skills.
• Ability to provide leadership, set priorities and be accountable to timelines.
• Presentation skills to be able to represent the laboratory related topic for the higher management.
• Experience in specifications and QC Bioburden and Sterility ,Endotoxina nd environmental monitoring methods in a regulated pharma industry.
• Excellent soft skills, including communication, teamwork and adaptability.
• Good record keeping skills and writing abilities.
• Working knowledge of various computer software such as word processing, spreadsheet, and database applications ( Myprocess).

What We Offer

• Competitive compensation and benefit package
• „Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance
• Opportunity to learn and develop
• Good team spirit and friendly colleagues
• Stable international company background
• Multinational working environment

Xellia Pharmaceuticals is the global leader in fermentation-based, non-beta-lactam anti-infectives, supplying Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries.

Recognized by the World Health Organization and the European Union for our critical medicines, we play a vital role in combating severe infections and antimicrobial resistance. Headquartered in Denmark, we operate manufacturing sites in Copenhagen, Denmark; Budapest, Hungary; and Taizhou, China, with R&D and commercial operations in seven additional locations globally. As the only European manufacturer of several key anti-infectives and with a heritage spanning over 120 years, we are driven by purpose and progress.

With more than 1100 employees, our impact starts from within. We offer a workplace where ideas, curiosity, and initiative thrive, and where your role evolves with your ambition. Instead of rigid structures, we provide real responsibility, freedom to explore, and support to grow. Together, we shape not only the future of our company and the development of our people, but also the health of communities worldwide.

Further information about Xellia can be found at: www.xellia.com
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