Quality Lead

Who We Are

Since 1990, we’ve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide.

From compounding and natural products to software, equipment, and genomics — we deliver smart, ready-to-use solutions that make healthcare better.

We’re passionate, science-driven, and always looking for new ways to improve lives.

Explore your future at Fagron Career Site.

About The Job

• Lead and mentor the Quality team to achieve quality objectives
• Maintain and continuously improve Quality Management System (QMS)
• Develop, implement, and maintain quality management systems, processes, and procedures
• Monitor product or service quality throughout the production or delivery lifecycle
• Conduct root cause analysis for quality issues and implement corrective and preventive actions (CAPA)
• Review quality metrics, prepare reports, and present findings to management
• Ensure compliance with applicable industry standards, customer requirements, and regulatory guidelines according to GMP
• Plan and conduct internal quality audits
• Collaborate with production, procurement, operations, and customer service teams to resolve quality issues and complaints
• Identify opportunities for process improvement using quality tools
• Manage customer complaints, non-conformance reports, and corrective action tracking
• Develop and deliver quality training programs for employees
• Drive a culture of continuous improvement and quality excellence
• Prepare the site for regulatory inspections and customer audits
• Ensure compliance with regulatory agencies and other applicable health authorities
• Support responses to audit observations and implementation of corrective actions
• Oversee investigations related to deviations, non-conformances, customer complaints, and out-of-specification (OOS) results
• Review and approve Corrective and Preventive Actions (CAPA) to ensure timely and effective closure
• Manage change control activities and assess quality risks associated with process or system changes
• Ensure timely review and approval of Standard Operating Procedures (SOPs), batch manufacturing records (BMRs), validation documents, protocols, and reports
• Review and approve GMP documentation, validation protocols, qualification reports, and quality records
• Perform equipment qualification, process validation, cleaning validation, and computerized system validation activities
  
  

Set yourself apart

You possess the following qualifications, background and abilities:

• Bachelor’s degree (Pharmacy, Chemistry, Biology, Chemical Engineering)
• 2+ years experience is preferable
• Excellent written and verbal communication skills
• Fluent in English
  
  

What's on offer?

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Ready for the challenge?

Take the next step and join us in shaping the future of personalized medicine. Apply today at careers.fagron.com.

Please note: we do not accept agency referrals for this position.