QC & Training Manager – Clinical Trials (Quality Compliance & Training)
Company: Sun Pharma Laboratories Ltd
Business Unit: Clinical Research
Location: Vile Parle – Office, Mumbai, India
Job Type: Full-Time
Experience Required: Minimum 5+ Years in Clinical Research Quality (CRO/Pharma/Biotech)
Education: B.Pharm (Mandatory); M.Pharm / PG Diploma in Clinical Research (Preferred)
Posted On: February 16, 2026
About the Company
Sun Pharma Laboratories Ltd is a globally recognized pharmaceutical organization committed to scientific excellence, regulatory compliance, and ethical clinical research. The company operates under stringent ICH-GCP standards and global regulatory frameworks to ensure patient safety, data integrity, and audit readiness across its clinical development programs.
Role Overview
The QC & Training Manager – Clinical Trials will oversee end-to-end quality compliance activities across Clinical Trial Medical Science, Clinical Operations, Clinical Trial Supply Management (CTSM), and Clinical Data Management teams.
This role is accountable for maintaining 24x7 inspection and audit readiness, strengthening the Quality Management System (QMS), and ensuring regulatory compliance with ICH-GCP, Indian regulations, DCGI, US FDA, ICMR guidelines, and the Drugs & Cosmetics Act.
The position requires strong leadership in risk-based quality oversight, audit handling, SOP governance, CAPA implementation, and training management within a matrix global clinical research environment.
Key Responsibilities
Quality Management System (QMS) Leadership
Develop, implement, and maintain a robust QMS for the Clinical Research function
Ensure quality oversight in line with SOPs, ICH-GCP, Indian and global regulatory requirements
Maintain 24x7 audit and inspection readiness across Medical Science, Operations, Data Management, and CTSM teams
Periodically review vendor quality compliance and renewals
Clinical Trial Quality Oversight
Conduct quality review of study documents including Synopsis, Protocols, Clinical Study Reports (CSR), and appendices
Perform QC review of site feasibility, site initiation, monitoring reports, ethics submissions, logs, and close-out documentation
Oversee QC for Clinical Trial Supply Management including IMP handling, labeling, storage, temperature monitoring, and drug accountability
Ensure final QC review of study close-out activities including reconciliation, destruction, and archival
Risk Management & CAPA
Assist in designing risk assessment frameworks for new and ongoing trials
Implement risk-based QC plans aligned with study protocols
Identify process gaps and recommend corrective and preventive actions (CAPA)
Develop QC assessment tools and compliance tracking systems
Training & SOP Governance
Identify job-specific SOP training requirements for study teams
Ensure periodic review and maintenance of training files
Prepare QC-related SOPs and support review of department-specific SOPs
Coordinate onboarding and role-based compliance training programs
Electronic Systems & Documentation Oversight
Ensure effective utilization of electronic systems for TMF management, deviation tracking, milestone alarms, and protocol compliance
Maintain QC findings repository and present quarterly trend analysis to senior leadership
Ensure record traceability in line with regulatory requirements
Audit & Inspection Management
Handle regulatory audits and inspections (DCGI, US FDA)
Communicate QC findings within stipulated timelines
Organize periodic review meetings to drive corrective action plans
Performance & Continuous Improvement
Develop QC metrics and dashboards
Drive process improvements based on regulatory updates
Support preparation of clinical manuals such as IMP handling manuals and study plans
Required Skills & Competencies
Minimum 5+ years of experience in Clinical Research Quality within CRO, Pharma, or Biotech organizations
Strong experience handling DCGI and US FDA audits and inspections
In-depth knowledge of ICH-GCP, ICMR guidelines, Drugs & Cosmetics Act, and global clinical trial regulations
Experience in CAPA planning and quality audit processes
Strong analytical skills with the ability to identify inconsistencies and compliance risks
Experience working in matrix and global business environments preferred
Proficiency in Excel and Quality Management Systems
Excellent communication, stakeholder management, and conflict resolution skills
Detail-oriented, performance-driven, and proactive mindset
Work Environment
Full-time role based in Mumbai
Cross-functional collaboration across global clinical research teams
Regulatory-facing, high-compliance environment
Why Join Sun Pharma
At Sun Pharma Laboratories Ltd, quality and compliance professionals play a strategic role in safeguarding patient safety and ensuring data integrity across global clinical programs. The organization provides opportunities to lead regulatory-grade quality systems, drive innovation in clinical governance, and contribute to global healthcare advancement.
Disclaimer
This job description outlines the general responsibilities of the role. Duties may be modified or expanded based on business requirements. The organization reserves the right to assign additional responsibilities aligned with the candidate’s experience and qualifications.
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