PHARMAFull-time
Specialist, Global Product Quality Complaint Triage and Network
By Admin · Quality Assurance & Quality Control
HYDERABAD (IN)ONSITEPOSTED: 9/1/2026
PHARMAFull-time
HIRING ORGANIZATIONBRISTOL MYERS SQUIBBPharmaceuticals
BR
ROLE DEFINITION & RESPONSIBILITIES
Position Summary
Responsible for accurate and timely review, evaluation, and assignment of incoming Product Quality Complaints (PQCs) in a high-volume, high-complexity environment.
Process PQCs within established performance requirements, including processing within one business day and achieving greater than 99% Right First Time performance.
Maintain strong knowledge of applicable BMS procedures for processing Product Quality Complaints covering pharmaceutical, biological, device, and combination products.
Maintain expert knowledge of PQC intake routes and collaborative relationships with stakeholders responsible for complaint intake.
Core Responsibilities
Manage PQC mailboxes and other intake sources for incoming complaints.
Maintain knowledge of the BMS product network, product portfolio, and PQC defect categories to enable timely and right-first-time complaint processing.
Apply critical thinking and risk-appropriate timelines when triaging and processing PQCs.
Expedite critical-category complaints and deliver timely escalations to investigation sites, Market Quality, and senior management when appropriate.
Liaise with investigation sites to obtain high-quality, complete, and timely investigation reports for BMS Quality approval.
Assess reported information for accuracy and completeness and facilitate collection of additional information required for assessments and investigations.
Review sample photographs critically and determine sample-return requirements in support of complaint investigations.
Assess information and obtain additional data needed for product replacement and/or reimbursement processes where applicable.
Collaborate with upstream partners including Medical Information, Worldwide Patient Safety Case Intake & Processing, and third-party service providers such as call centers.
Collaborate with downstream partners including investigation sites and Market Quality to resolve triage assignment inaccuracies and issues.
Use appropriate communication channels, including phone and Teams, to resolve issues efficiently and support timely investigations.
Escalate unexpected or undesired trends identified during PQC processing to PQC management.
Continuous Improvement, Compliance & Quality Systems
Proactively support continuous improvement of PQC triage and network processes.
Work with stakeholders and PQC management to improve applicable performance metrics.
Review and close designated PQC record types according to applicable PQC procedures.
Maintain continuous inspection and audit readiness.
Provide Subject Matter Expert support during PQC audits and inspections.
Act as PQC SME for continuous improvement projects.
Perform owner-role activities for specified investigation types, including Suspect Product, Product Quality Complaints, Lack of Effect, Serialization, and related activities.
Metrics, Systems & Documentation
Provide inputs and insights for metrics covering PQC intake, triage, due diligence, sample/photo retrieval, investigation assignments, Right First Time processing, investigation completion, and timeline adherence.
Receive feedback and collaboratively support process improvements and process changes to strengthen Right First Time processing.
Generate ad-hoc Product Quality Complaint reports from Veeva Infinity.
Complete and document reconciliation of PQCs received and transferred between intake and processing partners according to BMS procedures.
Highlight and escalate reconciliation irregularities to PQC management and maintain required evidence in eQMS.
Maintain accurate and current data in PQC SharePoint sites.
Support timely archival of PQC-related documentation.
Support Network Quality, Distribution Quality, Product Surety, Serialization Operations, and Serialization Quality Operations organizations.
Participate in the PQC Community of Practice and Local Process Owner Community of Practice.
Technical & Regulatory Expertise
Apply knowledge of the global regulatory environment applicable to Product Quality Complaint processing.
Understand product formulation and presentation types and associated defect categories and patient-safety risks.
Apply knowledge across solid oral dosage forms, device/combination products, topical products, liquids, suspensions, powders, freeze-dried products, and parenteral products.
Apply risk-informed decision making to complex quality processes where patient safety is a primary consideration.
Demonstrate proficiency with electronic systems and databases used in a global quality environment, including Veeva Infinity, Verity, SAP, BMS Docs, CelDocs, SharePoint, Excel, Outlook, Teams, Word, PowerPoint, and SuccessFactors.
Qualifications & Professional Competencies
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Chemical Engineering, Bio-Engineering, or a related field.
Minimum 3 years of experience in a global pharmaceutical, biopharmaceutical, or device organization in a Quality role.
Strong professional English proficiency in reading, writing, and speaking.
Excellent communication with management, peers, and cross-functional groups.
Ability to work accurately and effectively in a fast-paced, high-volume environment.
Strong prioritization and multitasking capability.
Demonstrated risk-informed decision making with complex processes.
Highly organized, detail-oriented, and efficient working style.
Customer and partner-focused approach with ability to incorporate stakeholder feedback.
Ability to build and maintain collaborative relationships across geographic locations.
Preferred / Advantageous Experience
Quality Operations experience at a pharmaceutical manufacturing site is advantageous.
Previous global Product Quality Complaint management experience is advantageous.
Experience supporting audits, inspections, continuous improvement, and quality-system activities strengthens suitability.
BMS Values & Organizational Impact
Demonstrate accountability, inclusion, integrity, innovation, passion, and urgency.
Contribute to patient safety by ensuring accurate, compliant, risk-based, and timely handling of Product Quality Complaints.
Support global quality operations and cross-functional issue resolution while maintaining inspection and audit readiness.
Benefits & Work Environment
BMS describes a purpose-driven and inclusive culture focused on transforming patients' lives through science.
The company highlights opportunities for growth, supportive working conditions, flexibility, wellbeing, inclusion, and comprehensive benefits.
BMS states that it hires for skills and capabilities, not credentials alone, and encourages qualified candidates to apply even when their background does not perfectly match every requirement.
Disability accommodations and adjustments are available during the recruitment process.
REQUIRED VERIFIED SKILLS
Bachelor's Degree in Life Sciences/Pharmacy/Nursing/Chemical Engineering/Bio-Engineering or related field
Minimum 3 years Quality experience in global Pharmaceutical/Biopharmaceutical/Device organization
Product Quality Complaint processing
Global Regulatory Environment
Risk-Informed Decision Making
Critical Thinking
Quality Operations
PQC Triage
Complaint Investigation
Patient Safety
Product Defect Assessment
Regulatory Compliance
English Communication
Veeva Infinity
Verity
SAP
BMS Docs
CelDocs
SharePoint
Excel
Outlook
Teams
Word
PowerPoint
SuccessFactors
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
The supplied BMS posting does not disclose a salary range, bonus figure, or specific monetary benefits, so salary_min and salary_max are left blank. Compensation should be evaluated as a complete BMS total-rewards package, including applicable base salary, incentives, benefits, wellbeing programs, and flexibility. The minimum stated experience is 3 years in a relevant global Quality role, making this a mid-career Specialist opportunity rather than a fresher position.
ORGANIZATION CONTEXT & CULTURE
Bristol Myers Squibb is actively hiring for this position.
INDUSTRY: Pharmaceuticals
EXPECTED CAREER ROADMAP
This Specialist role can provide progression within global Product Quality, Quality Operations, complaint management, quality systems, investigation management, and broader pharmaceutical quality functions. Experience gained in global PQC triage, regulatory compliance, risk-based decision making, audit readiness, quality systems, and cross-functional stakeholder management can support future progression into Senior Specialist, Associate Manager, Quality Operations, Product Quality, Quality Systems, Complaint Management, or other global quality leadership roles. SME and continuous-improvement responsibilities also provide opportunities to move toward process-owner, quality excellence, or global network leadership positions.
APPLICATION ADVISORY
Emphasize the minimum 3 years of relevant pharmaceutical, biopharmaceutical, or device Quality experience prominently on the resume. Highlight Product Quality Complaint triage or complaint-management experience, global-market exposure, risk-based decision making, regulatory knowledge, investigation coordination, audit readiness, and Right First Time performance. Quantify complaint volumes, turnaround-time improvements, RFT percentages, investigation improvements, or quality-system improvements where possible. Mention hands-on experience with Veeva Infinity, SAP, SharePoint, Excel, or comparable quality systems. Prepare examples demonstrating critical thinking, patient-safety assessment, escalation of critical complaints, cross-functional collaboration, reconciliation, trend identification, and continuous improvement. Candidates with manufacturing-site Quality Operations or global PQC experience should make those areas highly visible.
RECOMMENDED TRAINING
1/5
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