Quality Manager, USA

Role: Serve as Quality Manager supporting US affiliate QMS operations and acting as backup Local Quality Officer for CSL Behring Inc. Main objectives include ensuring compliance with GMP, GDP, and local regulations; supporting product complaint, warehousing, logistics, and customer service quality activities; managing deviations impacting product release; and facilitating regulatory inspections. Responsibilities encompass maintaining global and local SOPs, overseeing audit programs with Global Supplier Quality, supporting recalls and counterfeit investigations, and driving continuous quality improvement initiatives. Requirements: Bachelor’s degree in a science or business discipline; minimum 5 years GMP experience in pharmaceutical manufacturing, medical devices, or related fields; familiarity with GDP systems preferred. Skills/competencies include strong leadership, collaboration, strategic thinking, change management, and effective communication; experience with SAP and GxP systems advantageous. High-Value: US pharmaceutical operations, GMP/GDP compliance, product release, deviations management, regulatory inspection readiness, and cross-functional collaboration. Work setup involves limited travel, supporting a global matrix organization.