Lead and supervise all Quality Assurance activities of the manufacturing plant.

Ensure compliance with cGMP and DGDA regulations, and applicable quality management systems.

Develop, implement, and continuously improve Quality Assurance policies, SOPs, and quality systems.

Review and approve batch manufacturing records, validation protocols, qualification documents, change controls, deviations, CAPA, and quality investigations.

Ensure effective implementation of risk management and data integrity principles across QA operations.

Coordinate internal audits, self-inspections, vendor qualifications, and regulatory inspections.

Monitor quality metrics and drive continuous improvement initiatives.

Provide technical guidance, coaching, and performance management for the QA team.

Collaborate closely with Production, QC, Engineering, and Warehouse, and Regulatory Affairs to ensure consistent product quality and regulatory compliance.

Support new product introduction, technology transfer, process validation, cleaning validation, and qualification activities.

Ensure inspection readiness and timely closure of audit observations.