Position Summary

The Corporate Quality Specialist role is part of Corporate Audits & Compliance team and is part of the team which is responsible for monitoring changes and updates to GXP regulations, trends within GXP and ensure that Xellia takes timely action. Furthermore, the role is to ensure advisory/support to Xellia’s global sites regarding inspections and/or critical and complex compliance questions.

Key Responsibilities

• Provide expert guidance and support within quality compliance to Xellia sites, internal and external projects (including Due Diligence, Supply Agreements, Quality Agreements, SOPs), thereby ensuring the License to Operate.
• Provide support as part of external GXP inspections performed by Health Authorities and ensure that response to potential observations is given in a way which allows all of Xellia to comply.
• Monitor trends (internal as well as external) of audit findings raised during inspections, customers and internal audits and communicate these concisely to management.
• Monitor and inform members of Quality Management Board (QMB) and other key personnel, e.g. QPs, of new or changes to relevant requirements to initiate a timely update of QMS if needed.
• Write new SOPs or update existing global procedures as per assignments.
• Review new and updated global procedures.
• Conduct/lead Internal Audits as per assignments.
• Interpret, build upon and comply with the company quality assurance standards.
• Identifying, defining, implementing, and collect and inspect data to measure/manage process performance.
• Elaborate, recommend and oversee improvement actions.
• Develop new standards for stakeholders (Production, QA, QC etc.) and design, with improvements as needed, and creating procedures across all service lines.
• Work with the Quality functions to design and maintain clear workflows and processes.
• Ensure that Xellia’s Global system is always inspection ready.
• Develop and create process training materials and roll-out plans to all sites.
• Measure and manage process performance.
• Participate in various projects and activities within CP.
• Support other ad-hoc tasks as per assignments.

Requirements

• Minimum 3-5 years of experience in the pharmaceutical industry and has worked in different areas of Quality, preferably also in Operations.
• Should have experience in Compliance area, Quality systems, Quality assurance, Quality control activities, and analytical data review.
• Must have a relevant Science Degree: chemistry / science background, e.g. Pharmacy, Biochemistry, Chemical engineering, etc.
• Strong cGMP and pharmaceutical knowledge and experience required: FDA/EMA or other regulatory experience preferred – be able to identify compliance gaps in Xellia sites and provide solutions to close the gaps.
• Strong communication skills.
• Collaborates well with stakeholders.
• Team player and independent contributor.
• Must possess a passion for and deep understanding of GXP.
• Have a good knowledge about GXP regulations from FDA and EMEA.
• Able to work team oriented as well as independently.
• Good interpersonal skills.

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
• 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 about Xellia can be found at: www.xellia.com
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