Quality Specialist Jobs at Bristol Myers Squibb | BSc Chemistry Candidates Apply Now
Quality Specialist Jobs at Bristol Myers Squibb. The Specialist, Global Product Quality Complaint Triage and Network role at Bristol Myers Squibb in Hyderabad is a critical quality function focused on patient safety, regulatory compliance, and global complaint management. This role offers experienced quality professionals the opportunity to work in a high-impact, global pharmaceutical environment while supporting science-driven innovation and life-changing medicines.
Company Introduction
Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients’ lives through science. We specialize in oncology, hematology, immunology, and cardiovascular disease, supported by one of the industry’s most diverse and promising pipelines. Our passionate employees are dedicated to driving innovations that create meaningful changes. We pride ourselves on bringing a human touch to every treatment we pioneer. Join us and make a difference.
Specialist, Global Product Quality Complaint Triage and Network
Location: Hyderabad – TS – IN
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 a high level of 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 the 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 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.
- 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 owner role for specified investigation types, eg 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 timely archival of PQC related documents
- Provide support to Network Quality, Distribution Quality, Product Surety, Serialization Operations, Serialization Quality Operations organizations
- Participate in PQC Community of Practice, Local Process Owner Community of Practice
Qualifications & Experience
Degree/Certification/Licensure
Bachelor of Science (Life Sciences, Pharmacy, Nursing, Chemical or Bio-Engineering or related field)
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 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, in 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 use of electronic systems & databases to support daily use in a fast-paced environment (VEEVA Infinity, Verity, SAP, BMS Docs, CelDocs
