Manager I Quality Assurance | Cluster Support

Role Overview: As a Manager I Quality Assurance | Cluster Support, your primary responsibility will be to provide guidance and support to Site Quality on closing non-compliances, lead 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. Additionally, you will act as a champion for building a "Culture of Quality" across the organization and ensure that all sites are prepared for Regulatory and Customer inspections at all times. Key Responsibilities: - Act as COE to provide guidance to Sites to ensure achievement of targets for Quality & Compliance as per Management's expectations. - Review site investigation reports for major/critical non-conformances and share comments with the 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 identified gaps. - Collaborate with other Cluster Site Quality, SGO Heads, Supply Chain, Business Development, R&D, IT, and RA for any specific requirements related to site Quality. - Track and monitor site performance for improving quality index, identify key challenges and improvement areas, and discuss action plans for improvement. - Support the development of a central strategy to respond to system-level audit observations, inspection findings, and implement corrective actions across sites. - Regularly update on the status of Regulatory inspections, CQA audits, and upcoming inspections. - Coordinate with the site for annual revenue and capex budget proposals, including new headcount proposals. - Identify and review Quality cost reduction initiatives as per management requirements. - Review, discuss, and track projects/initiatives/tasks (Cluster/Corporate) for completion and closure. - 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. Role Overview: As a Manager I Quality Assurance | Cluster Support, your primary responsibility will be to provide guidance and support to Site Quality on closing non-compliances, lead 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. Additionally, you will act as a champion for building a "Culture of Quality" across the organization and ensure that all sites are prepared for Regulatory and Customer inspections at all times. Key Responsibilities: - Act as COE to provide guidance to Sites to ensure achievement of targets for Quality & Compliance as per Management's expectations. - Review site investigation reports for major/critical non-conformances and share comments with the 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 identified gaps. - Collaborate with other Cluster Site Quality, SGO Heads, Supply Chain, Business Development, R&D, IT, and RA for any specific requirements related to site Quality. - Track and monitor site performance for improving quality index, identify key challenges and improvement areas, and discuss action plans for improvement. - Support the development of a central strategy to respond to system-level audit observations, inspection findings, and implement corrective actions across sites. - Regularly update on the status of Regulatory inspections, CQA audits, and upcoming inspections. - Coordinate with the site for annual revenue and capex budget proposals, including new headcount proposals. - Identify and review Quality cost reduction initiatives as per management requirements. - Review, discuss, and track projects/initiatives/tasks (Cluster/Corporate) for completion and closure. - 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 env