Senior Manager, Quality Assurance Specialist

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 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 rich in diversity 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, Position Summary

We are seeking a highly motivated and detail-oriented QA Specialist with expertise in Corrective and Preventive Action (CAPA) management The successful candidate will be responsible for identifying, analyzing, and implementing process improvements across various functions within the organization

This role will also involve managing the CAPA process to ensure compliance with regulatory requirements and continuous improvement of quality systems This role will ensure compliance with regulatory requirements and drive continuous improvement initiatives across the organization, Key Responsibilities Identify opportunities for process improvements by analyzing current workflows, systems, and procedures related to CAPA management, Lead cross-functional teams to drive process improvement projects from inception to completion, Manage the CAPA process, including the identification, investigation, and resolution of non-conformances, Act as a CAPA lead investigator to conduct and manage root cause analysis, perform impact assessment of GCP deviations, audits (investigator sites, protocols, process, vendors, systems, and others as required), inspections, quality events and serious breaches, Act as a subject matter expert (SME) to support the business develop robust CAPAs with adequate effectiveness checks resulting from deviations, audits (investigator sites, protocols, process, vendors, systems, and others as required), inspections, quality events and serious breaches, Presents investigation findings to key stakeholders across Global Drug Development (GDD) and/or Global Quality (GQ) and works with the business to track CAPAs & effectiveness checks (where relevant) to completion, Provide training and support to staff on process improvement methodologies and CAPA management, Monitor the effectiveness of implemented CAPAs and process improvements through data analysis and performance metrics, Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, to drive continuous improvement, and to streamline processes

Stay current with industry best practices and regulatory requirements related to process improvement and CAPA management, Develops CAPA metrics and trend analysis to identify areas of improvement and drive continuous improvement, Prepare and present reports on process improvement activities and CAPA status to senior management, Serve as the Infinity system superuser and provide training to users, as needed, Maintains strong and productive working relationships with key stakeholders throughout BMS with the ability to think enterprise wide
Fosters Teamwork and Inclusion: Practices inclusion and seeks different perspectives Builds effective teams committed to organizational goals; fosters inclusion and collaboration among teams to address relevant issues Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality Recognize Global Implications and diversity: Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one's own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches Demonstrates Adaptability: Handles day-today work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; show resilience in the face of constraints, frustrations or adversity; demonstrates flexibility Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses

Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new of modified approaches; brings perspectives and approaches together combining them in creative ways Other: Apply Quality Risk Management E Operational Excellence principles to drive risk-based decision-making, streamline processes and foster a culture of quality and continuous improvement within the organization Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to peers across the organization Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems, Qualifications & Experience In-depth knowledge of GCP guidelines (e-g ICH, FDA regulations), principles of Quality Assurance, and proven experience within Clinical Trial Execution (e-g prior experience as CRA or Clinical Trial Manager) Demonstrated problem solving ability and quality mindset Good interpersonal, oral and written technical communication skills are essential Drives for results and success; conveys sense of urgency and drives issues to closure; persists despite any obstacles Ability to work in a highly matrixed and complex environment Demonstrates strong critical thinking skills and ability to make ethical, scientifically sound recommendations or decisions for issues consistent with company policy, regulatory references, and business strategy Experience in leading investigations utilizing formal Root Cause Analysis tools is preferred (or the ability to obtain formal RCA training) Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines Experience using data analytics (i-e control charts, heat maps, histograms, box plots) Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies Fosters a culture in which people continually work to improve services, and work processes Maintains the confidentiality and security of information, data, documents, and records Escalates issues to appropriate people within department/organization Sense of diplomacy and discretion

Fluent in English, with proven professional working proficiency in English for reading, writing and speaking, 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, 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 Responsibilities 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