Principal Specialist QMS QA

Working with UsChallenging. 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 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. Read more: careers.bms.com/working-with-us.The Principal Specialist, Quality Assurance (QA) Quality Management System (QMS) is responsible for reviewing good manufacturing practices (GMP) documentation and ensuring that commercial products and materials meet required quality characteristics. QA is responsible for the technical aspects of quality assurance as it relates to the products and changes or events that may impact the products. The Principal Specialist, QA QMS works within the QA team to establish and maintain quality assurance systems necessary for ensuring operations are in compliance with current Good Manufacturing Practices. The Principal Specialist, QA QMS will also work cross-functionally to ensure that GMPs are followed while maintaining an efficient and effective program to meet production requirements. In addition, the incumbent is responsible for support and leadership within the Local Process Owner Organization(s) to continuously improve and harmonize global Quality Systems.REQUIRED COMPETENCIES:Requires advanced knowledge of current Good Manufacturing Practices (cGMP), Occupational Safety and Health Administration (OSHA), United States Pharmacopeia (USP) and European Pharmacopoeia (EP)Advanced knowledge of Quality Systems: Deviations, Corrective Action Preventive Action (CAPAs), Change Management, Product Quality ComplaintsAdvanced knowledge of Validation ProgramAdvanced knowledge of Risk ManagementAbility to critically assess project(s) and allocates resources to efficiently achieve goalsAbility to multi-task and be flexibleAdvanced teamwork and facilitation skillsAdvanced critical reasoning and decision-making skillsAble to fully interpret results and situations and articulate recommendations for resolutionAbility to broaden technical and scientific knowledgeIntermediate to advanced knowledge of fundamental scientific problemsAbility to provide input and build relationships internally and with cross-functional teamsAble to implement solutions independentlyAble to write and review reports with clarity and brevityAble to produce data reports with precisionKey ResponsibilitiesIndependently performs QA review and approval of Deviations, Change Controls and CAPAsPrimary lead for complex DeviationsIndependently performs QA review and approval of Change Control Requests (e.g., DCCs, CCRs) to ensure the proposed changes are justified, supported by data and have been appropriately validated where applicableLeads Investigations of Product Quality Complaint (PQC) investigationsInterfaces with all other quality groups within the company on quality systems issuesResponsible for conducting QA review and approval of Validation, Engineering and Quality Control protocols, test plans and summary reports. This responsibility includes Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) of equipment, process, facility, and method validation approvalsWorks with Plant Operations to ensure compliance with and understanding of cGMPs, standard operating procedures (SOPs), and policiesProvides guidance to other employees in interpretation of complex dataLeads assigned projects/initiativesRecognized Subject Matter Expert within the groupProvide sitewide oversight of status and compliance of records in the Quality Management System.Ensures reports are available for record statuses.Designs and enforces processes to ensure department-level ownership of quality record statusUtilizes site/department Tier processes to highlight quality records, including timeliness and criticality.Supports the site and Global Quality through the Local Process Owner (LPO) network.Functions as an LPO for various quality record processes (investigations, change controls, complaints, actions).Supports quality system enhancements in coordination with global teams.Maintains tools provided by global teams such as playbook, rubric and global checklists.Manages the site Change Control Review Board, Investigation Review Board (IRB), Deviation Review Board (DRB) and Triage processes.Manages the use of meeting norms, templates for presentations, and other tools.Performs the scheduling and creation of agendas and meeting minutes.Provides information needed for other quality processes.Provides trending/metrics as requested for use in Quality CouncilPerforms trending as needed on a department-level, process-level basis as needed.Produces the required Rubric Scoring Heatmaps on a monthly basis for investigation monitoring.Performs quarterly Deviation Monitoring trending, including authoring quarterly summary reports.Performs trending as needed on a department-level, process-level basis as needed.Performs all other tasks as assigned.Conducts on-the-job training (OJT) and instructor-led training (ILT) for new hiresEnsures timely completion of records to support turnaround and batch release and leads department efforts/initiatives to ensure timely completion of recordsPerforms all other tasks as assignedQualifications & Experience* Bachelor's degree in related science preferred* Minimum 7 years of relevant work experience required, preferably in quality assuranceIf 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 CareersWith 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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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: https://careers.bms.com/california-residents/Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.