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 - Partner with Manufacturing, QC, Engineering, Supply Chain, and other functions to ensure timely and effective investigations. - Collaborate with global affiliates to ensure consistent complaint intake, escalation, and documentation. - Work closely with Pharmacovigilance for medical complaint alignment and AE reporting.Regulatory Compliance & Inspection Readiness - Ensure all investigators are inspection-ready and capable of articulating investigation rationale and methodology. - Lead or support development of responses to regulatory findings related to complaint handling.CAPA & Continuous Improvement - Ensure CAPAs linked to complaint investigations are clearly defined, risk-based, implemented on time, and verified for effectiveness. - Review complaint trends, perform periodic quality metrics reporting, and identify recurring issues. - Lead global initiatives to improve investigation quality, complaint handling efficiency,



and system performance. - Drive harmonization and standardization of complaint investigation procedures across global sites.Systems Management - Serve as business owner or key user for the global complaint management system (e.g., TrackWise, Veeva QMS, EtQ). - Ensure investigators properly utilize QMS workflows and maintain high data integrity standards. - Partner with IT/TechOps on system enhancements and validations. Education - Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related field required. - Advanced degree (MS, MBA, PharmD) preferred. Experience - 7-10 years of experience in pharmaceutical or biotech quality systems. - Minimum 3 years directly managing complaint handling, quality investigations, or QA operations. - Experience managing, training, or mentoring investigators strongly preferred. - Experience supporting regulatory inspections (FDA, EMA, MHRA, etc.). Skills & Competencies - Deep understanding of GMP/GDP regulations. - Solid analytical and root-cause analysis skills (5 Whys, Fishbone, DMAIC, FMEA). - Excellent leadership, communication, and coaching abilities. - Strong organizational skills with experience managing workload prioritization. - Proficiency with electronic QMS platforms.Key Performance Indicators (KPIs) - On-time complaint closure rate. - Quality of investigations and recurrence reduction. - Investigator performance and capability development. - CAPA effectiveness rate. - Accuracy and timeliness of trend reporting. - Regulatory inspection outcomes related to complaints.

📌 Global Manager, Customer Complaints (Kukatpally)
🏢 DIFGEN PHARMACEUTICALS PRIVATE
📍 Kukatpally