Manufacturing Quality Assurance (MQA) Manager

The MQA Manager leads all production related quality assurance activities at Xellias Budapest site. This role ensures full compliance with regulatory standards oversees API release processes drives continuous improvement and manages the MQA Specialist team to maintain the highest levels of pharmaceutical quality and operational excellence.

Main Responsibilities

• Lead QA oversight for all manufacturing operations.
• Ensure compliance with relevant legislation GxP regulations and guidelines.
• Make release decisions for APIs intermediates raw materials and packaging materials.
• Handling deviations CAPAs change controls OOS investigations complaints and recall.
• Approve CoAs specifications stability protocols validation and other relevant documentation.
• Support cGMP inspection readiness and participate in audits/inspections.
• Drive continuous improvement across QA processes.
• Lead mentor and develop the MQA Specialist team.
• Act as GDP responsible person from quality point of view.
• Collaborate with Operations RA Logistics Business Operations Supply Chain and other stakeholders.

What We Expect

• MSc degree in Chemistry Biology Pharmaceutical Sciences or another relevant Life Sciences discipline.
• Advanced scientific education specialization in pharmaceutical-related fields is an advantage.
• Sterile manufacturing experience could be an advantage.
• Minimum 5 years of experience in the pharmaceutical industry in Quality Assurance Quality Control Manufacturing or a related function.
• At least 3 years of proven people leadership experience.
• Strong knowledge of pharmaceutical quality systems and a quality-first mindset.
• Ability to lead teams set priorities make sound decisions and deliver results within agreed timelines.
• Proactive decisive and capable of managing complex quality and compliance challenges.
• Excellent communication and stakeholder management skills with the ability to collaborate effectively across functions.
• Comfortable working in a dynamic international environment.
• Fluent English (written and spoken).

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
• Home Office opportunity

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 aboutXellia can be found at:
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