Experience Inc. Jobs

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 performs periodic Quality Control (QC) activities, including in-house reviews.

• 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), as needed

• Ensures that the QC and 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 findings, including identification of any process gaps and recommends appropriate actions.

• Collaborate and support Study Risk Management, at operational level

• 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.

• Supports QA in QMS Implementation. May act 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 GDs 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

• Bachelors Degree in Medicine/Pharmacy or any other Life Sciences. Masters Degree Preferred.

• Minimum 10 years of Clinical Research Experience, out of which at least 2-3 years experience of Oversight and On-site monitoring of global multi-centric clinical trials.

• Previous experience of handling audits & regulatory inspections preferred.

• Previous experience of Quality Assurance / Compliance is preferred.

• Good knowledge of Quality Management Systems, Quality Risk Management, Trend Analysis and CAPA implementation.

• 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.

• 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)

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