Clinical Research Job at Sun Pharma in India
Interested in a leadership role in Clinical Quality and Sponsor Oversight? Sun Pharmaceutical Industries Ltd is hiring a Manager – Clinical Process and Quality Manager for its Global Development Center. This Clinical Research Job in India is ideal for professionals experienced in clinical research, RBQM, sponsor oversight, quality systems, and global clinical trial operations. The role at Sun Pharma Careers focuses on ensuring inspection readiness, risk-based quality management, CRO oversight, and compliance with ICH-GCP and global regulations. Candidates will work closely with global development teams, quality assurance functions, and external stakeholders to strengthen clinical quality frameworks and oversight models.
About the Company:
Sun Pharmaceutical Industries Ltd is one of the world’s leading specialty generic pharmaceutical companies with a strong global presence across multiple therapeutic areas. The company focuses on innovation, research-driven development, and affordable healthcare solutions.
Through its Global Development Center, Sun Pharma drives clinical development, regulatory excellence, and quality-focused operations worldwide. The company promotes a culture of growth, collaboration, innovation, and continuous learning while supporting employees in building impactful careers.
Job Details:
- Job Role: Manager – Clinical Process and Quality Manager
- Department: Global Development Center
- Job Grade: G11A/G10
- Job Location: Gurgaon / Mumbai
- Employment Type: Full Time
- Industry: Pharmaceutical / Clinical Research
- Functional Area: Clinical Quality & Sponsor Oversight
- Experience Required: 10+ Years Global Clinical Research Experience
- Travel Requirement: Up to 30%
Key Responsibilities:
Sponsor Oversight & Accountability
- Maintain Sponsor Oversight frameworks for CROs, vendors, and investigational sites
- Ensure Sponsor accountability throughout the clinical trial lifecycle
- Assess and escalate quality risks, compliance gaps, and emerging signals in this Clinical Research Job
- Support senior leadership during audits and regulatory inspections
- Monitor vendor and CRO performance against quality and regulatory standards
Integrated Quality Control (IQC) Activities
- Plan and conduct risk-based IQC reviews
- Perform remote and on-site QC visits
- Conduct focused reviews of high-risk processes, vendors, and sites
- Ensure compliance with protocols, SOPs, and regulatory requirements in this Job in India
- Document QC outcomes for inspection readiness and traceability
Risk-Based Quality Management (RBQM)
- Lead RBQM implementation in line with ICH E6(R3)
- Identify Critical-to-Quality (CtQ) factors
- Develop study-level risk assessments and Quality Management Plans
- Perform signal detection, trend analysis, and risk reviews at Sun Pharma Careers
- Ensure proactive quality planning and issue prevention strategies
Audit, Inspection & Issue Management
- Support regulatory inspections and audit readiness activities
- Participate in audit responses and post-inspection follow-up
- Ensure effective CAPA implementation and root cause analysis
- Collaborate with QA teams on serious GCP non-compliance and quality events
- Support governance oversight and documentation activities
Reporting & Governance
- Prepare structured quality oversight reports
- Analyze IQC findings and recurring quality risks
- Recommend process improvements and corrective actions
- Translate lessons learned into training and enhanced oversight strategies
Quality Systems & Continuous Improvement
- Review and develop SOPs and controlled documents
- Support training implementation related to RBQM and Sponsor Oversight
- Monitor adherence to SOPs and compliance standards
- Support QMS implementation and quality initiatives
- Evaluate impact of changing regulations on clinical operations
- Participate in continuous process improvement activities
Educational Requirements for this Clinical Research Job:
- Educational Qualification: Advanced Degree in Medicine
- Preferred Qualification: Master’s Degree
- Experience Required: 10+ Years Global Clinical Research Experience
- Required Expertise: Sponsor Oversight and On-site Monitoring of Multi-centric Trials
Skills Required:
Technical Skills
- Strong expertise in ICH-GCP and global regulations
- Knowledge of Sponsor Oversight and RBQM frameworks
- Clinical Quality Management expertise
- Experience with QMS, CAPA, and trend analysis
- Audit and inspection readiness management
- CRO, vendor, and investigator oversight experience
- Risk assessment and quality signal detection skills
- Clinical trial compliance monitoring expertise
Behavioural Skills
- Stakeholder engagement and collaboration
- Communication and negotiation skills
- Strategic thinking and analytical mindset
- Leadership and governance capabilities
- Attention to detail and quality-focused approach
- Problem-solving and escalation management
- Adaptability and a continuous learning attitude
Benefits of the Clinical Research Job:
- Opportunity to work with a leading global pharmaceutical company
- Exposure to international clinical development operations
- Leadership role in clinical quality and RBQM
- Career growth in Sponsor Oversight and Clinical Quality Management
- Collaborative and innovation-driven work environment
- Learning and professional development opportunities
- Exposure to audits, inspections, and global regulatory processes
- Opportunity to contribute to advanced clinical trial quality systems
- Supportive workplace culture focused on growth and teamwork
