External Quality Operations Manager

📋 Description

• Lead quality oversight of CMOs, ensuring manufacturing and distribution comply with Sobi’s quality
• Act as a QP delegate for EU batch release, reviewing batch documentation and completing delegated
• Support CMO qualification and maintain QTAs that clearly define quality responsibilities.
• Manage deviations, CAPAs, complaints and change requests, ensuring timely resolution and escalation
• Review product quality and stability reports, using risk assessments and KPIs to guide remediation
• Support CMO audits, inspection readiness and health authority inspections and audits of Sobi.

🎯 Requirements

• University degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry
• More than five years’ experience in pharmaceuticals or biotechnology within quality assurance
• More than one year’s experience managing external quality oversight of CMOs
• Ability to provide degree certificates, transcripts and course descriptions for assessment
• Fluent written and spoken English
• Desired: More than two years’ experience in global operations

🎁 Benefits

• Opportunities for professional growth
• Competitive compensation for your work
• Diversity and Inclusion
• A flexible workplace that supports work-life balance