09 Sep
|
DIFGEN PHARMACEUTICALS PRIVATE
|
Kukatpally
09 Sep
DIFGEN PHARMACEUTICALS PRIVATE
Kukatpally
Position Summary
The Global Manager, Customer Complaints is responsible for the global oversight, execution, and continuous improvement of the pharmaceutical complaint management program. This role leads a team of complaint investigators and ensures all product quality complaints are properly triaged, investigated, documented, and closed in compliance with international regulations and internal quality standards.Key Responsibilities
Complaint Management & Oversight
- Lead the end-to-end global complaint process including intake, triage, assignment, investigation, documentation, and closure.
- Assign complaints to investigators based on expertise, workload, product knowledge, and investigation complexity.
- Ensure complaints are processed in compliance with FDA, EMA, MHRA, Health Canada, WHO, and other relevant regulations.
- Review and approve complaint investigations, interim assessments, and final reports for technical accuracy, regulatory compliance, and completeness.
- Establish and track performance metrics for complaint processing (e.g., on-time closure,
investigation quality, backlog reduction).Management of Complaint Investigators
- Directly lead and develop a team of complaint investigators (onsite, remote, or global).
- Provide coaching, technical guidance, and escalation support on complex investigations and root-cause analysis.
- Conduct routine 1:1s, performance reviews, and competency assessments for complaint investigators.
- Ensure investigators are trained on applicable SOPs, regulatory expectations, and investigation tools/methodologies.
- Monitor workload distribution and adjust assignments to ensure timely complaint closure and balanced productivity.
- Conduct periodic quality reviews of investigator work, identifying areas for improvement and coordinating retraining when necessary.
- Develop and maintain a culture of scientific rigor, accountability, and continuous improvement among the investigation team.Cross-Functional Collaboration
- Partn
📌 Global Manager, Customer Complaints (Kukatpally)
🏢 DIFGEN PHARMACEUTICALS PRIVATE
📍 Kukatpally