Manager I Quality Assurance | Cluster Support

As a Manager in Quality Assurance | Cluster Support, your role involves providing guidance and support to Site Quality on closing non-compliances, leading enhancement projects related to product quality, compliance, and simplification. You will set milestones for effective execution of project actions and maintain substantial compliance at all sites by harmonizing and implementing Quality Systems and procedures in alignment with Global Policies and Standards. Your responsibilities include acting as a champion for building a "Culture of Quality" across the organization and ensuring that all sites are ready for all Regulatory and Customer inspections at all times. Key Responsibilities: - Act as COE to provide guidance to Sites to ensure achievement of target for Quality & Compliance as per Management's expectation. - Review site investigation reports for major/critical non-conformances and share comments with site for improvement of root cause analysis. - Support site for audit readiness by performing gap assessment through site visits and/or document review remotely for compliance enhancement and to track the action plan for remediation of gaps identified during Visit/Review. - Collaborate with other Cluster Site Quality, SGO Heads, Supply Chain, Business Development, R&D, IT and RA for any specific requirement related to site Quality. - Review and discussion on batch rejection, market complaint, FAR/Recalls, Invalidated OOS - Monthly tracking, review and collation of details and discussion with site Quality for action plan. - Support the development of central strategy to respond to system level audit observations, inspection findings and implement corrective actions across sites. - Coordinate with site for annual revenue and capex budget proposal including new headcount proposal. Work with Cluster Head to review and submit final proposal to corporate functions (Finance/HR/MDO). - Identify and review Quality cost reduction initiatives as per management requirements. - Work closely with Cluster Quality Head for reviews, identifying actionable points and ensuring closures. Qualifications Required: - Experience in a pharmaceutical organization with good exposure to Quality and Manufacturing Operations. - Strong knowledge of GMPs in both domestic and international regulatory environments. - Strong communication skills, goal-oriented, excellent negotiation skills, relational skills, and ability to communicate effectively with all levels of the organization and external stakeholders.,