Site Self Inspection Lead, Quality Assurance - 1st Shift

Role: Site Self Inspection Lead responsible for developing, executing, and tracking site self-inspection plans to ensure regulatory compliance and continuous improvement. Responsibilities: lead and participate in internal inspections, oversee CAPA development and verification, prepare trend reports, support site audit readiness, and conduct external audits of third-party suppliers; provide training on GMP and inspection processes; support quality culture initiatives. Requirements: Bachelor's degree in Science, Engineering, or related field; minimum 10 years' experience in GXP settings with extensive knowledge of pharmaceutical cGMP, global regulations (FDA, EMA, WHO, ICH, ISO 9001), and quality systems. HighValue: pharma manufacturing, GxP compliance, cGMP, site audit readiness, global regulations, quality assurance, external and internal inspections, CAPA management. WorkSetup: not specified; requires in-depth regulatory and quality expertise.