Manager-1-clinical Quality

6 months ago

Gurugram Haryana, India Sun Pharmaceutical Industries Ltd Full time

**Job Purpose**

The Clinical Process and Quality Manager (CPQM) is primarily responsible to support all Global Development (GD) functions for ensuring audits and inspection readiness through periodic quality control activities.

**Key Roles and Responsibilities**
- Acts as Quality Partner for assigned Global Development Functions and drives Quality Initiatives.
- Leads, drives and supports periodic Quality Control (QC) and Inspection Readiness activities.
- Travels and Performs On-Site QC visits and helps Investigators / Site staff for audit & inspection readiness.
- Participates in Audits and Regulatory Inspection activities (preparation, conduct and post audit/inspection management).
- Ensures that the QC, Audit and Inspection findings are appropriately investigated, CAPAs are effectively implemented and lessons learned shared and implemented.
- Works closely with the Quality Assurance team and assigned GD functions and/or Contract Research Organizations (CROs) for managing cases of scientific misconduct, Serious GCP Non-Compliances, Quality Issues, assist in assessing root cause analysis, CAPA implementation.
- Performs trend analysis of all QC, audit, inspection observations, including identification of any process gaps and recommends appropriate actions.
- Provide periodic reports to stakeholders on quality related matters, risk assessment and specific quality improvement initiatives.
- Identifies and assesses risks and suggests risk mitigation strategies in collaboration with the assigned GD functions.
- Monitors adherence to SOPs and report on compliance issues, works with assigned GD function heads to address any deviations or areas of improvement.
- Supports in SOP development, training and overall tracking related activities for all GD functions.
- Becomes Reviewer for SOPs / Processes for the assigned GD functions.
- Acts as Coordinator for LMS & EDMS and Initiator / Evaluator for Trackwise as needed.
- Reviews global documents and assesses its implementation for various GD functions.
- Reviews, assesses impact of international/national regulations and guidelines on GD’s operations.
- Participate in Global Super User led meetings or other cross functional activities, as needed.
- Assists with continuous improvement efforts related to Global Clinical Quality Management.

**Qualification, Skill and Competencies Requirements**
- Bachelor’s Degree in Medicine/Pharmacy or any other Life Sciences. Master’s Degree Preferred.
- At least 10 years of experience in Clinical Research out of which 5 years’ experience of on-site monitoring of global multi-centric clinical trials.
- Previous experience of Quality Assurance / Compliance and have faced / handled audits &/or regulatory inspections
- Previous experience of interacting with Investigators, KOLs, CROs and managing quality issues.
- Strong operational understanding of ICH-GCP and Global Clinical Trials
- Good Knowledge of pertinent international, national regulations & guidelines.
- Good knowledge of Quality Management Systems. Experience Preferred.
- Exemplary organization, communication and stakeholder management skills.
- Strong negotiation skills and experience of managing difficult conversations / stakeholders.
- Ready to travel for 50% of time.

**Job Duration**

Full Time Part time

**Job Location**

Mumbai / Gurgaon / Princeton (USA)

**Reporting To**

Head - Global Clinical Quality Management (GCQM)

**Job Grade**

Manager-1 (G10)

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