Corporate Quality Specialist
- København
- Permanent
- Fuldtid
QualityAbout the jobAt 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.)
- The position requires travelling to Xellia sites
- Close co-operation with the rest of the CQS team and Xellia sites team
- 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
- 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
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