Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: .Position SummaryAs the Manager, Global Product Quality Complaints Device & Digital, you have expertise and experience in digital tools for optimal PQC processing and have expert knowledge in the management of complaints related to device/combination products.Reporting to the Senior Manager, Global Product Quality Complaints, HYD Lead, you will act as the Subject Matter Expert (SME) for device/combination products complaints, supporting continuous improvement initiatives, risk management, and mitigation strategies. You will also be responsible for delivering digital and automation solutions in line with BMS's digital strategy, ensuring their compliance with internal and global regulatory requirements. Your role includes designing, operating, and maintaining automation/RPA solutions and collaborating with stakeholders to resolve BOT operation issues, thereby minimizing interruptions to PQC processing. Additionally, you will partner with various teams to ensure effective data exchanges and support for adverse event investigations, identify critical quality issues, and develop corrective actions. You will also provide SME support for PQC trending activities and maintain technical expertise in business applications such as Spotfire.Key Responsibilities

• Responsible to maintain a high level of knowledge & understanding of Pharmaceutical/Biologic Quality Assurance, Device Quality Assurance, cGood Manufacturing Practices as applicable in global GMP regulations (including FDA, EMA, MHRA, PMDA, ENVISA, TGA).
• Responsible to act as the Subject Matter Expert (SME) for processing of complaints related to devices and combination products. Responsible to engage and support Device Quality organization in continuous improvement of device complaint handling and data management. Responsible to support the risk management and mitigation related to device complaint management.
• Responsible for delivery of digital and automation solutions in line with the BMS digital strategy for PQC optimization.
• Ensure quality & compliance of digital solutions and automations with internal and global regulatory requirements, including evolving regulatory landscape.
• Accountable for the optimum design, operation and maintenance of automation/BOT solutions for PQC related processes. Responsible to work effectively and collaboratively with stakeholders business partners to escalate and resolve BOT operation issues, in order to minimise interruption to PQC processing and to maintain budget adherance.
• Provide ongoing management for PQCs ensuring compliance to global framework of GMP policies and BMS procedures
• Partner with WWPS to ensure effective exchanges through integrated systems and investigation for Adverse Events with PQC MedDRA codes
• Identify critical quality issues and assist in the investigation and implementation of corrective actions.
• Provide SME support for PQC trending activities using business applications such as Spotfire (PQC-MVT) and maintain technical expertise with regards to its build and operations
• Develop trusting, open and collaborative partnerships while ensuring stakeholders (affiliates, sites, functions) have clear understanding of PQC processes from intake to closure
• Oversee and improve reconciliation processes from intake sources (Medical Customer Engagement and WWPS)
• Provide SME support, liaise with ancillary groups for Device/Combination products ensuring robust processes and controls for Medical Device Reporting (MDR) and Device Malfunction assessments
• Lead quality risk management activities for complaint handling and promote the understanding of risk management for product quality complaints and surveillance activities and participate in project teams as needed.
• Manage all aspects of quality systems, such as documentation, trainings, change controls, quality agreements and computer system validations as necessary for complaint handling.
• Partner with global metrics team and PQC/PS support analytics teams to establish and generate complaint metrics and Key Performance Indicators (KPIs) and facilitate improvements for end-to-end complaint process.
• Conduct self-inspections on a periodic basis and provide support during audits and inspections Support Community of Practice forums with collection of topics, content preparation and presentation.
• Support PQC related audits and inspections as necessary

As required by the Senior Manager HYD PQC Lead:

• Act as a delegate for Global Product Quality Triage support the management of the Global Product Quality Complaint (PQC) handling process from receipt to closure according to applicable timeframes and in compliance with BMS procedures and regulatory requirements
• Act as a delegate for the Manager, Global Product Quality Complaints Surveillance, completing PQC data assessments, highlighting trends, signals and risks and business critical information related to Product Quality Complaint data to Quality leadership in a timely fashion. Data & trend assessments will be communicated with stakeholders in a manner commensurate with risk and enabling appropriate action taking to protect BMS and our patients.
• Act as delegate for PQC Systems lead, ensuring optimal performance of system interfaces impacting PQC processing.

Qualifications & ExperienceDegree/Certification/LicensureBachelors degree or higher in Life Sciences (Chemistry, Biology etc) or Health Sciences (Nursing, Pharmacy etc) or related discipline eg Engineering, Pharmaceutical Manufacturing etc.Advanced degree preferred.Qualification or proven experience in data analytics, automation or similar highly advantageous.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
• Excellent ability to analyse processes, data and trends, and to translate into effective messaging to stakeholders and leaders supporting effective decision-making
• Proven ability to understand complex processes/problems and propose alternate solutions/automated solutions/process enhancements/efficiencies
• Experience in management of PQCs related to globally distributed pharma/BIO and device/combination products
• Customer and partner focus, including the ability to listen to and incorporate feedback from key stakeholders
• Demonstrated Enterprise mindset to be able to think and act across functions and divisions
• Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
• Highly organized, detail oriented, efficient operator in a fast-paced environment
• Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats
• Demonstrated strategic thinking capability and ability to balance conflicting priorities
• Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance
• Ability to clearly articulate digital needs to functional partners

Experience Responsibility and minimum number of years

• A minimum of 5 years of experience in a Quality role where data analytics and/or process automation was a key component in the pharmaceutical/ biotech/ device industry
• Strong working knowledge/experience with systems such as QMS, SAP/ERP, Veeva, automations
• Prior experience in the management of Product Quality Complaints for Pharma/BIO/device/clinical products is an advantage
• Experience with device/combination products
• Experience with understanding how to respond to trend signals within the context of quality surveillance
• Strong problem solving skills are required
• Strong program and project management skills
• Ability to manage multiple, simultaneous projects
• Thorough understanding of Quality Risk Management
• Mastery of relevant Quality compliance processes and regulations

If you come across a role that intrigues you but doesnt 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 sciencexe2x84xa2 , 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 ProtocolBMS 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 consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol-Myers Squibb