Quality Manager, USA

Role: Quality Manager supporting CSL Behring USA affiliate operations, serving as backup Local Quality Officer. Responsibilities: ensure compliance with local GMP/GDP regulations and CSL global standards; support Product Technical Complaint process; manage deviations and corrective actions; oversee warehousing, logistics, customer service, and product release; facilitate recalls and counterfeit investigations; collaborate with Global Supplier Quality and update SOPs; evaluate regulatory changes; drive continuous improvement; prepare for regulatory inspections; support quality system enhancements. Requirements: bachelor’s degree in business or science; minimum 5 years in GMP quality or systems in pharma manufacturing, medical devices, or related fields; experience with GDP systems preferred; strong communication, collaboration, and negotiation skills; capable of working in a global, matrix organization. Competencies: results-oriented, customer-focused, collaborative, strategic, change agent, analytical, self-motivated; excellent communication and computer skills, experience with SAP beneficial. HighValue: GMP/GDP compliance, pharmaceutical manufacturing, product release, recalls, global quality systems, FDA inspection readiness. WorkSetup: primarily office-based with limited travel.