Role & responsibilities:
- Lead and own the organization's Quality Management System (QMS) across all business functions.
- Ensure the QMS complies with internal policies, customer requirements, and applicable regulatory standards.
- Drive continuous improvement initiatives to enhance the effectiveness and efficiency of quality processes.
- Plan, conduct, and lead internal quality audits in accordance with established audit programs.
- Support customer, certification, and regulatory audits, ensuring timely closure of audit observations.
- Analyze audit findings and quality data to identify trends, risks, and opportunities for improvement.
- Manage non-conformances and oversee effective implementation of Corrective and Preventive Actions (CAPA).
- Monitor, measure, and review internal business processes to ensure compliance and operational excellence.
- Develop and track quality metrics and Key Performance Indicators (KPIs) to measure QMS effectiveness.
- Present QMS performance, audit outcomes,



and quality improvement initiatives to senior management during business review meetings.
- Coordinate QMS-related training programs and promote awareness of quality policies, procedures, and best practices across the organization.
- Collaborate with cross-functional teams including IT, HR, Product Development, Business Development, and Operations to integrate quality requirements into business processes.
- Ensure compliance with quality, information security, and data privacy frameworks including ISO 9001, ISO 27001, SOC 2, HIPAA, GDPR, and applicable pharmaceutical/CRO regulations.
- Support Computerized System Validation activities and ensure validated systems remain compliant throughout their lifecycle.
- Ensure quality practices are embedded within the SDLC, leveraging electronic Quality Management System tools to drive process standardization and continual improvement.

key Skills:
- Quality Management Systems (QMS) & Electronic QMS (eQMS)
- ISO 9001, ISO 27001, SOC 2,

📌 QA Lead (Bengaluru)
🏢 Clinevo Technologies
📍 Bengaluru