QMS Executive / Associate - Clinical Research Quality Assurance

Why This Role Matters
The QMS Associate / QMS Executive plays an important role in maintaining quality and regulatory compliance within a Clinical Research Organization. The position supports the implementation and monitoring of the Quality Management System (QMS), ensuring that clinical research activities follow global regulatory standards and best practices.

Job Description
The QMS Executive will support quality assurance activities including internal audits, regulatory compliance monitoring, documentation control, and continuous improvement of quality systems. The role ensures that clinical research operations align with regulatory guidelines such as ICH-GCP while maintaining proper documentation and audit readiness.

Key Features of the Role
• Opportunity to work in Quality Management within a Clinical Research Organization
• Exposure to global regulatory standards including ICH-GCP, USFDA, EMA, and CDSCO
• Involvement in internal audits, compliance monitoring, and quality improvement initiatives
• Collaboration with cross-functional teams including clinical operations and pharmacovigilance
• Professional growth in clinical research quality systems and regulatory compliance

Responsibilities
• Implement and monitor Quality Management System (QMS) processes in accordance with global regulatory guidelines
• Conduct internal audits, vendor audits, and study-related audits to ensure compliance with SOPs and regulatory requirements
• Assist in preparation, review, and maintenance of SOPs, CAPAs, deviations, and change control documentation
• Support regulatory inspections and client audits by ensuring documentation readiness and compliance
• Maintain training records and ensure staff compliance with required quality and regulatory training programs
• Identify process gaps and recommend corrective and preventive actions to improve quality systems
• Maintain accurate documentation, record-keeping, and archival systems
• Collaborate with departments such as Clinical Operations, Pharmacovigilance, Data Management, and Regulatory Affairs
• Support continuous improvement initiatives to strengthen CRO quality standards

Required Qualifications

Educational Requirements:
• Doctor of Pharmacy (Pharm.D) – Mandatory

Experience and Skills:
• 5–10 years of experience in Quality Management Systems or Quality Assurance within the clinical research industry
• Strong knowledge of QMS principles and audit practices
• Understanding of clinical research processes including clinical trials, pharmacovigilance, and regulatory submissions
• Knowledge of regulatory guidelines such as ICH-GCP, CDSCO, USFDA, and EMA
• Excellent documentation, analytical, and problem-solving skills
• Strong communication and presentation abilities
• Ability to manage multiple tasks and maintain strict timelines

Salary Insights:
• Salary offered as per company norms

Benefits
• Health Insurance
• Provident Fund

Company Overview
Forward Life Pvt. Ltd. is a growing Clinical Research Organization providing services in clinical operations, pharmacovigilance, regulatory affairs, and quality management. The organization follows global regulatory standards and focuses on maintaining high-quality research practices across pharmaceutical and healthcare projects.

FAQs
• What qualification is required for this role?
Candidates must hold a Doctor of Pharmacy (Pharm.D) degree.

• How much experience is required?
Applicants should have 5–10 years of experience in Quality Assurance or Quality Management Systems within the clinical research industry.

• Where is the job located?
The position is based in Hyderabad, Telangana, India.

• What type of work will the candidate perform?
The role focuses on QMS implementation, internal audits, compliance monitoring, and regulatory documentation management.

Application Tips
• Highlight experience with Quality Management Systems and clinical research compliance
• Mention experience with audits, CAPA management, and SOP documentation
• Showcase knowledge of ICH-GCP and other global regulatory guidelines
• Include examples of process improvement and quality assurance initiatives
• Demonstrate strong documentation and regulatory compliance skills