Manager 1 Clinical Quality & Process

Job Description

bTitle: Manager-1-Clinical Quality & Process Date: May 3, 2024 Location: Gurgaon - R&D Company: Sun Pharmaceutical Industries Ltd 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 GDxe2x80x99s 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

• Bachelorxe2x80x99s Degree in Medicine/Pharmacy or any other Life Sciences. Masterxe2x80x99s Degree Preferred.
• At least 10 years of experience in Clinical Research out of which 5 yearsxe2x80x99 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 xe2x80x93 Global Clinical Quality Management (GCQM) Job Grade Manager-1 (G10)