Clinical Quality Assurance Manager

Veeda CR; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Veeda CR in Ahmedabad, India, seeks a Quality Assurance professional to develop, maintain and enhance the organization's QMS and related controlled documents for clinical operations. You will plan and conduct internal audits, review TMF records, ensure regulatory compliance, prepare audit reports and CAPAs, and guide teams on applicable regulations.

You will monitor quality metrics, assess external vendors, and support continuous improvement through SOPs, ISMS, data protection, and industry best

Responsibilities

• Support the Quality Director in developing, enhancing, and maintaining the organization's QMS and related controlled documents for clinical operations.
• Collaborate to establish clear, measurable quality objectives aligned with regulatory requirements and industry standards.
• Promote communication and implementation of quality objectives to foster a strong quality culture.
• Design and deliver quality-related training programs to increase awareness and adherence to quality standards and best practices.
• Plan, conduct, and manage internal audits and inspections to evaluate QMS effectiveness and identify improvements.
• Perform quality reviews of Trial Master File documentation to ensure completeness, accuracy, and regulatory compliance.
• Conduct routine compliance checks against trial plans, protocols, sponsor requirements, and regulatory standards.
• Prepare audit reports identifying gaps and CAPAs and provide guidance on applicable regulations and guidelines.
• Develop and monitor study-specific quality metrics and KPIs to assess performance and provide insights to leadership.
• Prepare compliance and quality reports highlighting trends, risks, and improvement opportunities.
• Evaluate external vendors via assessments and audits to ensure performance and compliance.
• Review protocols, reports, deviations, CAPAs, and related records for accuracy and regulatory compliance.
• Execute day-to-day quality activities per SOPs, GCP, protocols, sponsor requirements, and regulatory guidelines.
• Stay updated on regulatory changes and best practices to support continuous improvement of systems and procedures.
• Maintain QMS, ISMS, data protection regulations, and other applicable national and international requirements.
• Develop, update, and maintain clinical quality documents, SOPs, work instructions, guidelines, and templates.

Job description

Key Responsibilities:

1. Quality Management System (QMS) Development

• Support the Quality Director in the development, enhancement, and maintenance of the organization's Quality Management System (QMS) and controlled documents related to clinical operations.
• Collaborate with the Quality Maintenance Manager (QMM) to establish clear, measurable quality objectives aligned with organizational goals, regulatory requirements, and industry standards.
• Promote the effective communication and implementation of quality objectives across all levels of the organization to foster a strong quality culture.
• Design and deliver quality-related training programs to increase awareness, understanding, and adherence to quality standards, regulations, and best practices.

2. Quality Assurance, Compliance, and Auditing

• Plan, conduct, and manage internal audits and inspections (e.g., site audits, trial-specific audits, data management audits) to evaluate QMS effectiveness and identify improvement opportunities.
• Perform quality reviews and audits of Trial Master File (TMF) documentation, including both paper-based and electronic records, to ensure completeness, accuracy, and regulatory compliance.
• Conduct routine compliance checks to verify adherence to clinical trial/study-specific plans, protocols, sponsor requirements, and regulatory standards, ensuring continuous audit readiness.
• Prepare comprehensive audit reports identifying compliance gaps, process deficiencies, and areas of risk, while recommending appropriate corrective and preventive actions (CAPAs).
• Provide guidance and consultation on applicable regulations, guidelines, and industry standards governing clinical research and clinical trials.

Quality Documentation and Performance Reporting

• Develop and monitor study-specific quality metrics and key performance indicators (KPIs) to assess study team and site performance, providing actionable insights to the Quality Director.
• Prepare periodic compliance and quality reports highlighting trends, risks, non-compliance observations, and improvement opportunities.
• Evaluate and monitor the qualification, compliance status, and performance of external vendors and suppliers through assessments and audits.
• Review clinical trial documentation, including protocols, reports, protocol deviations, CAPAs, and related records, to ensure accuracy, completeness, and compliance with regulatory requirements.

Policies, Procedures, and Continuous Improvement

• Execute day-to-day quality activities in accordance with applicable policies, processes, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), study protocols, sponsor requirements, and regulatory guidelines.
• Stay informed of emerging industry trends, regulatory updates, and best practices in quality management, contributing to the continuous improvement of systems, processes, and procedures.
• Ensure full compliance with the organization's Quality Management System (QMS), Information Security Management System (ISMS), data protection regulations, and other relevant national and international legislative requirements.
• Develop, update, review, and maintain clinical quality documents, including SOPs, work instructions, guidelines, and templates to support quality and compliance objectives.