Associate Director Quality Control/First Line Manager QC – Sweden Biomanufacturing Centre
Core
Lead and develop Quality Control (QC) operations for biological and parenteral products at the Sweden Biomanufacturing Center, ensuring compliance with cGMP and registered requirements while driving digitalization and automation initiatives.
Role type
Associate Director / First Line Manager, Quality Control
Builds
Analysis results, validated analytical methods, and qualified status of instruments for biological and parenteral products.
Domain
Biopharmaceuticals / Biomanufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, laboratory operations leadership, team development, change management, regulatory inspection experience, strategic planning, cross-functional collaboration
Preferred skills
automation and digitalization in laboratory environments, biological product QC, qualification and validation, LEAN methodology
Technologies
Laboratory automation systems, digitalization tools
Responsibilities
Lead and develop QC operations to create clear direction and engagement for the team; Drive change and improvement related to digitalization, automation, and innovation; Ensure delivery of analysis results within agreed lead times; Support analyst technical transfers of new methods; Ensure qualified status of analysis instruments and equipment; Ensure regulatory compliance with cGMP and registered requirements; Drive systematic work environment efforts in line with legislation and permits
Seniority
Senior, hands-on IC with leadership responsibilities
