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Quality Management System Process Lead - Deviations & CAPA -

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: August 9, 2019

Job Description:

The purpose of this role is to ensure consistent global leadership for key Quality processes, including but not limited to one or more processes in the Quality Management System Process Architecture. The Process Lead (PL) is accountable to drive initial process optimization and improvement following standard methodology, to ensure resources are identified and aligned at the team-level to drive process optimization activities, and lead optimization to align with the GxP document hierarchy. This will include serving as the key point of contact for assigned process(es). The PL will ensure role definition and clarity on key accountabilities for process steps through an enterprise lens and ensure that process interdepencies are understood and optimized. In addition, the PL will establish, track, and trend process metrics to achieve Quality Outcomes that ultimately drives continuous improvement working across the matrix in a Community of Practice fashion with Local Process Owners (LPO), other Process Leads (PL), and Subject Matter Experts (SME).The PL role reports into the Global Process Owner (GPO) who is accountable to provide high-level oversight, set strategy for the process and ultimate decision making in optimizing and the ongoing sustainability of the process. The GPO will serve as executive oversight and primary decision-maker including budgetary decisions for assigned processes. The GPO will provide decisions required and oversight to Process Leads (PL) including resolution of escalated issues, endorse and monitor metrics to achieve Quality Outcomes, and support Community of Practice.Overall responsibilitiesIn close collaboration with the Global Process Owner, serve as the process lead for a QMS process ensuring it remains in a state of control and is both effective and efficientSupporting the process architecture of the integrated Quality Management System (QMS), lead a process workstream designed to monitor and improve said process(es) within the integrated GxP QMS frameworkWork effectively across the matrix by engaging with the broader process owner network and local site or function process owners in designing and deploying QMS process improvements. Identify and track progress against key project milestones partnering with applicable business, quality and other enabling functions and any external providers to ensure overall project successActively engage with leadership from business case development through program delivery, broker the delivery of critical programs within the portfolio, ensure organizational alignment on scope, schedule, quality, benefits and implement and monitor appropriate controls to proactively deal with barriers to completionNavigate cross-functional team through ambiguity towards to a clear and actionable decisionParticipate/lead regulatory surveillance and benchmarking initiatives with peers externally to stay abreast of changes in regulations that affect impacted processes and also to identify new ways of working and evolving technologies in this spaceDefine and lead the development of metrics through standard queries and reports with system functionality60%-Develop, Deploy, and Maintain Assigned ProcessesMaintain global processes, procedures, and training materials in compliance with Global GxP requirements, BMS Global Quality Standards, and BMS' Quality Management System (QMS) principles of integrated, patient-centric, and risk-based decision-makingSupport deployment of global process by close cooperation with relevant functions and site/country leadsProvide training, support, and coaching as requiredDefine Community of Practice (COP), including roles, operating mechanisms, communication strategies, and levels of training and accessLiaise with Quality Leadership Team and other functional leaders to identify and empower COP membersProvide leadership, coaching, and training for COP including both the technical processes and the behaviors necessary to optimize process executionDefine process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including both product/clinical trial quality and process effectiveness aspectsSupport site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responsesCollaborate with other PLs and SMEs to drive optimal execution of process across BMS and external partnersSupport or manage high-priority, cross-functional eventsMaintains global expertise through ongoing training and participation in industry forums30%-Continuous Process ImprovementUtilize metrics and COP operating mechanisms to identify and prioritize process improvementsProvide data and input to drive other continuous improvement efforts across the enterprise as applicable, which may include priority and timing collaboration with other PLLead efforts to scope, plan, and implement process improvements including accountability for sustainable improvements, such as process, procedure, systems, and training material changes; and use of appropriate change management and communication principlesEnsure continuity of process and support systems through major initiatives (e.g. integration, divestiture, or reorganization); serve/lead program teams or sub-teams, manage interim state of operations, ensure establishment of defined future state of processes, as applicableMaintain awareness of Culture of Excellence across BMSRequired Travel 40 to 50% for select process lead roles to ensure processes are globally designed and deployed in an effective and inclusive manner where extensive iterative process design development, training and sustaining of processes are required.10%-IT System SupportSupport development, approval, and execution of business case approval for improvement projectsServe on systems project teams and committees to ensure that all system issues and opportunities are accommodated in a timely, effective, and Right First Time mannerEducation:Minimum of a Bachelor degreein a Natural Science, Pharmacy, or other Healthcare-related fieldMaster's Degree and/or PMP certification with 10 plus years experience in pharmaceutical industry in concentrated disciplines of R&D, Operations, Validation, and/or Quality preferredExperience/Knowledge:GeneralThorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality and serious breach investigationsFamiliar with electronic quality system toolsStrong program and project management experience with proven track-record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects, preferably in QualityDemonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting prioritiesExperience with partner managementSpecific to relevant GCP processesUnderstanding of clinical developmentMastery of relevant Quality compliance processes and regulations, e.g. Good Clinical Practices (GCP)A minimum of 5-7 years of clinical operations, regulatory, pharmacovigilance, or other relevant biopharmaceutical industry experienceSpecific to relevant GMP/GLP processesUnderstanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processesMastery of relevant Quality compliance processes and regulations, e.g. Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)A minimum of 10 years of experience in quality operationsA minimum of 12-15 years of experience in pharmaceutical operationsSkills/Competencies:Demonstrated influential leadership expertise and experience with senior level interactions and influence with R&D/GPS functional areas and Global QualityDemonstrated Enterprise mindset to be able to think and act across functions and divisionsDemonstrated 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 objectivesDemonstrated people management experienceExcellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)Strong and demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balance conflicting prioritiesDemonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlinesDemonstrated change agility in anticipating and leading others through change and ambiguityAbility to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance

Keywords: Bristol-Myers Squibb Company, New Brunswick , Quality Management System Process Lead - Deviations & CAPA -, Executive , New Brunswick, New Jersey

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