Interview Process: 2 Rounds (Initial Screening + Hiring Team Panel) We are seeking an experienced QA Operations Lead to support clinical finished product quality operations within a highly regulated pharmaceutical environment. The ideal candidate will have extensive Quality Assurance experience supporting clinical supply operations, product release, supplier quality, investigations, CAPA management, and regulatory compliance. Key Responsibilities Lead quality oversight for clinical finished product release and distribution activities. Review and approve investigations, ensuring root cause analysis and effective CAPA implementation. Manage deviations, complaints, change controls, and supplier quality activities. Lead quality agreement negotiations and supplier risk management for packaging and labeling CMOs. Review and approve quality documentation in accordance with GxP requirements. Provide Quality Assurance guidance to cross‑functional stakeholders regarding compliance and regulatory expectations. Drive continuous improvement initiatives, change management activities, and quality risk assessments. Analyze quality metrics and develop KPI reports using digital reporting tools. Support internal audits and regulatory inspections while maintaining inspection readiness. Collaborate with Clinical Supply Chain, Manufacturing, Regulatory, and external partners to ensure compliant execution of quality processes. Required Qualifications Bachelor’s degree in Pharmacy, Biology, Chemistry, Engineering, or related scientific discipline (or equivalent experience). Minimum 8 years of Quality Assurance experience within the pharmaceutical or biopharmaceutical industry. Strong understanding of GMP/GxP regulations. Experience supporting clinical supply chain quality operations. Experience managing deviations, investigations, CAPA, complaints, and change controls. Experience with supplier quality management and quality agreements. Strong root cause analysis and risk assessment skills. Experience supporting regulatory inspections and audit readiness. Excellent communication and cross‑functional collaboration skills. Preferred Qualifications Experience with Veeva Vault as a Quality Approver (Highly Preferred). Experience using Power BI, Smartsheet, Microsoft Copilot, or similar digital reporting tools. Experience supporting packaging and labeling Contract Manufacturing Organizations (CMOs). Knowledge of quality metrics, KPI reporting, and continuous improvement methodologies. #J-18808-Ljbffr
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