Quality Assurance – Director

• Quality System Leadership: Direct and oversee the Quality Management System (QMS), ensuring compliance with FDA, EMA, ICH, and other applicable global regulatory requirements.

• Policy & SOP Governance: Author, review, approve, and maintain quality policies, procedures, and documentation governing GMP operations, ensuring consistent application across development and commercial programs.

• Inspection Readiness: Maintain a continuous state of regulatory inspection readiness and lead all regulatory inspections, customer audits, and third-party quality assessments.

• Quality Culture: Promote and reinforce a culture of quality, compliance, and accountability across all functional areas.

• Batch Record Review & Disposition: Provide quality oversight for manufacturing and testing activities, including review and approval of batch records and final product disposition.

• Deviation & Investigation Management: Ensure timely investigation of deviations, OOS/OOT results, complaints, and quality events, with effective root cause analysis and sustainable CAPA implementation.

• Change Control Oversight: Lead quality review and approval of change controls, evaluating regulatory impact and ensuring changes are implemented in a controlled and compliant manner.

• Risk Management: Apply quality risk management principles to support development, scale-up, and commercial manufacturing activities.

Cross-Functional Leadership & Continuous Improvement

• Business Partnership: Collaborate closely with Manufacturing, Technical Operations, Supply Chain, and R&D to ensure quality is integrated into operational and strategic decision-making.

• Metrics & Performance Monitoring: Establish, track, and report key quality metrics to assess system effectiveness and drive continuous improvement initiatives.

• Process Optimization: Identify and implement opportunities to improve quality processes, enhance compliance efficiency, and support scalable organizational growth.