Bangalore SENIOR MANAGER KA

Job description

SENIOR MANAGER 10/14/26 Company Overview Role Purpose Academic Stream SCIENCE Work experience (in months) 240 Job Responsibility and key Decisions Quality Oversight of RD Activities Manage QA oversight of nonclinical and clinical RD studies including method development, process development, and pilot manufacturing. Ensure compliance with applicable regulatory frameworks GLP, GMP, GCP. Audit Inspection Management Plan and lead internal audits of RD labs, processes, and documentation. Support external regulatory inspections and customer audits by preparing teams and documentation. Document Control Review Oversee review and approval of RD SOPs, protocols, reports, and batch records to ensure accuracy and compliance. Ensure proper document management and archiving according to quality systems. Deviation CAPA Management Lead investigation and root cause analysis of deviations, nonconformances, and quality incidents in RD. Manage corrective and preventive actions CAPA and monitor their effectiveness. Training Quality Culture Develop and deliver training programs on QA requirements, compliance, and best practices for RD personnel. Promote a strong quality culture emphasizing data integrity and regulatory compliance. Risk Management Conduct risk assessments for RD processes and support mitigation strategies to prevent quality issues. Crossfunctional Collaboration Collaborate with RD, regulatory affairs, manufacturing QA, and quality control to align quality standards and address compliance issues. Audit Scope Prioritization Determine audit focus areas based on risk, previous findings, and regulatory expectations. Disposition of Nonconformances Decide on acceptability and corrective actions for deviations, outofspecifications OOS, and quality incidents. Approval of Quality Documentation Review and approve critical RD documents ensuring compliance and completeness. Training Needs Quality Improvements Prioritize training topics and continuous improvement initiatives based on audit outcomes and quality trends.