SENIOR MANAGER

Company Overview

Role Purpose

Academic Stream

Work experience (in months)

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.