At Xellia, the Corporate Quality Systems (CQS) team plays a vital role in shaping and strengthening the foundation of our global Quality Management System. We work across all sites and functions to ensure regulatory compliance, drive continuous improvement, and support the delivery of safe, effective medicines to patients worldwide.
As part of the CQS team, you’ll join a dynamic, international group of experts dedicated to building robust processes, developing global standards, and maintaining inspection readiness across the organization. This is a unique opportunity to collaborate with key stakeholders, influence company-wide quality practices, and contribute directly to Xellia’s mission of safeguarding lives.
If you are an ambitious Quality expert, who wants to influence the compliance level across Xellia sites — your next challenge starts here!

Main Responsibilities:

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
Prepare and review Xellia’s SOPs related to CP
Ensure that Xellia’s Global system is always inspection ready
Elaborate GMP procedures (API/FDF) and guidelines to improve Quality Management System (QMS) at Xellia
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
Escalate compliance issues to immediate superior with potential/sizeable impact/risk to Xellia Pharmaceuticals business/company reputation.
Act as Subject Matter Expert (SME) during customer audits/regulatory inspections
Act as Process owner for Global Quality Systems (Trackwise, myProcess and vLMS etc.)

Other requirements:

The position requires travelling to Xellia sites
Applicants must be based in Budapest
Close co-operation with the rest of the CQS team and Xellia sites team 
 

What we expect: 

Minimum 5 years of experience in the pharmaceutical industry and has worked in different areas of Quality, preferably also in Operations
Should have experience in Analytical assurance, Quality control activities, and analytical data review
With chemistry / science background, e.g. Pharmacy, 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
 

What we offer: 

You will have a lot of impact to the overall compliance in Xellia
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

If you are interested in the position, please visit us at booth B8.