Manager, Quality, PPC - Surgery

Role: Quality and Regulatory Compliance Leader at a large biopharma manufacturing site, responsible for ensuring quality standards, regulatory adherence, and process efficiency across supply chain activities including Production, Process Control, and Supplier Quality. Objectives include maintaining site audit readiness, driving continuous quality improvement, and fostering a strong quality culture. Responsibilities: oversee quality planning, represent GE HealthCare to external regulatory agencies, lead quality communications, and manage Corrective and Preventive Action (CAPA) activities. Authority includes stopping production, issuing product holds, approving releases, and signing off on milestones such as NPI. Requirements: Bachelor's degree with 6+ years in regulated medical device/pharma industry or 10+ years with a high school diploma; 2+ years of supervisory or project leadership experience; knowledge of FDA CFR 21 820, ISO 13485, and other international quality standards; excellent communication skills and proficiency with QMS tools. Preferred: 5+ years supervisory experience, process development and project management skills, experience with change management, cross-functional collaboration, and leading internal/external audits. High-Value: medical device/pharma manufacturing, site quality leadership, regulatory compliance, risk management, quality systems (QMS, ISO, FDA), and continuous improvement methodologies. Work setup: location not specified; no travel requirements stated.