Quality Manager, USA

Role: Quality Manager supporting US affiliate operations within a biopharma manufacturing environment, with responsibilities spanning QMS support, regulatory compliance, product release, deviation management, and global quality collaboration. Acts as backup Local Quality Officer and liaises across manufacturing, logistics, and global quality teams. Ensures adherence to GMP and GDP standards, manages audits, supports recalls and counterfeit investigations, and drives continuous improvement initiatives. Requirements: Bachelor's degree in science or business; minimum 5 years' GMP quality or systems experience in pharmaceutical manufacturing, with familiarity in GDP systems preferred. Strong communication, collaboration, and negotiation skills essential; experience with SAP is advantageous. HighValue: GMP/GDP compliance, pharmaceutical manufacturing, GMP/GDP regulations, deviation and CAPA management, global regulatory inspections, and cross-functional stakeholder engagement. Work Setup: limited travel; based in the US, supporting affiliate operations and collaborating with global teams.