Bristol Myers Careers: Quality Specialist | Chemical Engineering Jobs
Are you looking for an exciting opportunity as a Quality Specialist in a global pharmaceutical organization? The Specialist, Global Product Quality Complaint Triage and Network role in Hyderabad at Bristol Myers Squibb offers a dynamic platform to grow within Bristol Myers careers. Ideal for professionals exploring Chemical Engineering Jobs and pharmaceutical quality operations, this position provides hands-on exposure to global complaint triage, regulatory compliance, and patient-focused quality systems in a high-impact environment.
About Bristol Myers Squibb
mal">Bristol Myers Squibb is a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With strong expertise in oncology, hematology, immunology, and cardiovascular disease, the company operates across multiple international locations, including India. Through Bristol Myers careers, professionals in roles such as Quality Specialist and other Chemical Engineering Jobs contribute to global quality systems, advanced manufacturing, and regulatory excellence. Driven by the mission of transforming patients’ lives through science™, BMS fosters a culture of innovation, integrity, inclusion, and collaboration worldwide.
Job Title: Specialist, Global Product Quality Complaint Triage and Network
Location: Hyderabad – TS – IN
Qualifications: Bachelor of Science (Life Sciences, Pharmacy, Nursing, Chemical or Bio-Engineering, or related field)
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 for maintaining high-level knowledge and understanding of applicable procedures appropriate to the processing of Product Quality Complaints for BMS products (Pharmaceutical, Biological, Devices, Combination products).
Responsible for maintaining expert knowledge and understanding of PQC intake routes and maintaining collaborative partnerships with stakeholders for intake of PQCs.
Responsible for managing PQC mailboxes as a source of intake for PQCs.
Responsible for maintaining knowledge of BMS product network, product portfolio, and PQC defect categories with respect to BMS products, commensurate with the 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 for delivering timely escalations to investigation sites, market quality, and senior management as appropriate.
Responsible for liaising with investigation sites to deliver high-quality, on-time, comprehensive investigation reports for BMS Quality approval.
Responsible for assessing reported information for accuracy and completeness, and facilitating 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, e.g., 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, TEAM preferred over email).
Escalate to PQC management unexpected/undesired trends observed during processing of PQC records.
Apply proactive means to support continuous improvement of the triage & network processes for PQC. Engage actively with stakeholders and PQC management to continuously improve applicable performance metrics.
Perform review and closure of designated PQC record types as prescribed in PQC procedures.
Be PQC inspection & audit-ready at all times.
Provide Subject Matter Expert (SME) support during audits and inspections for PQC.
Act as PQC SME for continuous improvement projects.
Perform activities related to the owner role for specified investigation types, e.g., Suspect Product, Product Quality Complaints, Lack of Effect, Serialization, etc
As required by PQC management and Network Quality Leadership:
Provide inputs and insights to metrics assessments for PQC intake, triage, due diligence activities, sample/photo retrieval, investigation assignments, RFT processing through investigation completion, adherence to timelines, etc
Receive feedback and align collaboratively on improvements and/or process changes to support Right First Time processing of PQC records
Generate ad-hoc reports from VEEVA Infinity related to Product Quality Complaints
Complete & document reconciliation of PQCs received and transferred between intake and processing partners as prescribed by BMS procedures. Highlight & escalate irregularities to PQC management for timely resolution. Maintain evidence of all reconciliations in eQMS are required by applicable procedures.
Maintain accurate and current data in PQC SharePoint sites
Support the timely archival of PQC-related documents
Provide support to Network Quality, Distribution Quality, Product Surety, Serialization Operations, and Serialization Quality Operations organizations
Participate in the PQC Community of Practice, Local Process Owner Community of Practice
Required Competencies
Fluent in English, with proven professional working proficiency in English for reading, writing, and speaking
Excellent communication with management, peers, and other functional areas
In-depth understanding of the global regulatory environment with respect to Product Quality Complaint processing
Excellent understanding of product formulation* & presentation* types, defect categories applicable to each, and the inherent risk that defect types pose to patient safety *(Solid Oral Dose, Device/Combination, Topical, Liquid/Suspension/Powder/Freeze-Dried Parenteral, etc)
Ability to apply critical thinking in a high-volume, fast-paced environment, with the knowledge that decisions taken support patient safety
Ability to prioritize while balancing multiple tasks
Demonstrated experience in risk-informed decision-making while working with complex processes
Highly organized, detail-oriented, efficient operator in a fast-paced environment
Customer and partner focus, including the ability to listen to and incorporate feedback from key stakeholders
Ability to build and maintain collaborative relationships with stakeholders in multiple geographic locations by engaging transparently, performing reliably, and delivering on commitments
Excellent proficiency in the use of electronic systems & databases to support daily use in a fast-paced environment (VEEVA Infinity, Verity, SAP, BMS Docs, CelDocs, Sharepoint, Excel, Outlook, Teams, Word, PowerPoint, SuccessFactors)
