Quality Management• Lead and direct quality initiatives/activities such as continuous improvement (CI), cost improvement projects (CIP), new product introduction (NPI), supplier quality management (SQM), stability program, product quality review, etc.• Lead and direct all GMP-related activities (including but not limited to change control, document control, deviation control, calibration, quality control batch, batch review, CoA generation, production positive release, quality manuals, non-conformances, CAPA, recall, customer complaint, customer return, reprocessing, retention, risk management, verification and validation, internal and external audits, management review, etc).• Ensure quality system compliance to ISO 9001, and other standards as required and customer requirements.• Work with organization-wide functions to implement error-proofing efforts; prevent issues that could lead to sub-optimal product quality.• Conduct quality process capability studies; identify continuous improvement opportunities within existing processes.• Enable organization-wide transformation and improvement initiatives to close gaps.Quality Control and Audit Management• Co-ordinate to customers regarding the audit activities like Quality system audit, Etgical/Social Compliance audit, C-TPAT audit.• Implement quality standards and ensure effective inspection and testing activities.• Making suppliers audit plan and ensuring that audit is going as per plan, Raising NCs, Review the CAP.• Visit/audit to suppliers regarding new part development.• Oversee investigations into major quality deviations to determine root causes.• Evaluate the impact of quality deviations on operations and the need for corrective and preventive actions (CAPAs).• Translate internal and external quality-related audit policies into procedures and checks to be followed.• Organize quality-related internal audits and coordinate external audits; ensure site-inspection readiness for audits and visits.• Review audit results and the proposed changes to procedures.• Introduce additional training programs to address gaps identified from audits and checks.Supplier Quality Management• Facilitate the linkage of quality performance to sourcing decisions; establish standards for suppliers.• Work with supply chain and provide an evaluation of supplier selection and ongoing performance; review and approve supplier; monitor and ensure required improvement of the supplier.Quality Information System• .