Specialist, Global Product Quality Complaint Triage

Working with Us Challenging Meaningful Life-changing Those aren t words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here uniquely interesting work happens every day in every department From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it You ll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives Read more 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 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 Sharepoint Excel Outlook TEAMs Word Powerpoint SuccessFactors Experience - Responsibility and minimum number of years A minimum of 3 years of experience in a global Pharmaceutical Bio-pharmaceutical Device organization in a Quality role Industry experience in a Quality Operations role on a manufacturing site is an advantage Prior experience in management of Product Quality Complaints for global markets is an advantage BMS BioPharma Values The qualified candidate demonstrates characteristics of our BMS Values Accountability Inclusion Integrity Innovation Passion Urgency If you come across a role that intrigues you but doesn t perfectly line up with your resume we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work Life-changing Careers With a single vision as inspiring as Transforming patients lives through science TM every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential site-by-design field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100 of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50 onsite at your assigned facility For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation adjustment prior to accepting a job offer If you require reasonable accommodations adjustments in completing this application or in any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff customers patients and communities As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will 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