Job
Description
Position Summary As the Specialist for Global Product Quality Complaint Triage, you will be responsible for the accurate and timely review, evaluation, and assignment of incoming Product Quality Complaints (PQCs) in a dynamic, high-volume environment. Reporting to the Associate Director of Global Product Quality Complaints, you will work closely with various stakeholders across the organization to ensure compliant and efficient management of PQCs. Your role will involve maintaining a thorough understanding of applicable procedures and PQC intake routes, managing PQC mailboxes, and liaising with investigation sites to deliver high-quality, comprehensive investigation reports. You will apply critical thinking and risk-appropriate timelines to expedite the processing of critical complaints, ensuring timely escalations and accurate assessments. Your responsibilities will also include supporting continuous improvement initiatives, being audit-ready, and providing subject matter expertise during audits and inspections. Additionally, you will engage proactively with both upstream and downstream partners to resolve issues and support the overall quality management system. Your ability to prioritize, manage multiple tasks, and maintain collaborative relationships with stakeholders globally will be essential in driving the success of the PQC processes. Key Responsibilities Responsible for accurate & timely review, evaluation and assignment of incoming Product Quality Complaints (PQCs) in a fast-paced, high-volume, high-complexity environment within established performance requirements (within one business day, >99% Right First Time). Responsible to maintain high level knowledge and understanding of applicable procedures appropriate to processing of Product Quality Complaints for BMS products (Pharmaceutical, Biological, Devices, Combination products). Responsible to maintain expert knowledge and understanding of PQC intake routes and maintain collaborative partnerships with stakeholders for intake of PQCs. Responsible to manage PQC mailboxes as a source of intake for PQCs. Responsible to maintain knowledge of BMS product network, product portfolio, and PQC defect categories with respect to BMS products, commensurate to delivery of timely and right first time processing of Product Quality Complaints from receipt and through to investigation assignment. Ensure that critical thinking and risk-appropriate timelines are applied to the triage and processing of PQCs. Expedite category complaints will be managed with due urgency. Responsible to deliver timely escalations to investigation sites, market quality, and senior management as appropriate. Responsible to liaise with investigation sites to deliver high quality, on-time, comprehensive investigation reports for BMS Quality approval. Responsible to assess reported information for accuracy and completeness, and to facilitate the collection of required data and information to support timely assessments and investigations. Apply critical thinking in the receipt & review of sample photographs, and in the determination of sample return requirements in support of complaint investigations. Assess provided information and secure required additional information as required to support product replacement and/or reimbursement processes where applicable. Engage proactively, collaboratively & timely with upstream partners (Medical Information, Worldwide Patient Safety Case Intake & Processing, Third Party Service providers eg Call Centers etc) and with downstream partners (investigation sites, market Quality etc) to resolve triage assignment inaccuracies and issues to deliver timely resolution and support timely investigation processes. Use risk & time appropriate communication means to engage with and resolve issues with upstream & downstream partners (phone, TEAMs preferred over email). Escalate to PQC management unexpected/undesired trends observed during processing of PQC records. Job Type: Full-time Pay: ₹700,000.00 - ₹1,100,000.00 per year Work Location: In person
