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Manager, Global Quality Serialization and Product Surety

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: March 26, 2020

Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.Summary:The purpose of this role will provide Quality support for establishing, optimizing and sustaining global Quality Serialization and Product Surety processes. The Manager Global Quality Serialization and Product Surety is accountable to support process optimization and improvement. This will include serving as a key point of contact within Quality for Serialization and Product Surety process (es) including suspect product investigation and product authentication. In addition, this position will support, track, and trend process metrics to achieve Quality Outcomes that ultimately drives compliance and continuous improvement working across the matrix with Serialization, Corporate Security, Global Quality Analytical Science and Technology, Packaging Technology, BMS sites and associated internal and external functions.Responsibilities:--- Accountable to support the effective and efficient execution of Serialization and Product Surety process as well as ensure full compliance with all internal and external regulatory requirements--- Accountable to support Serialization and Product Surety process optimization, improvement and long term sustainability within Quality--- Support the alignment of resources to drive Serialization and Product Surety process optimization for Quality--- Lead and support alignment of GxP document practices across the enterprise--- Manage and support defined optimization metrics to ensure Quality outcomes and monitor performance for associated process (es).--- Support the development and maintenance of global Serialization and Product Surety processes within Quality, procedural documents, 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-making--- Support global Serialization and Product Surety processes for Quality with close cooperation and input from relevant functions and site/country leads--- Support Serialization and Product Surety process monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms--- Support site and function teams during regulatory inspections or audits--- Collaborate with stakeholders to implement best practices and support optimal execution of Serialization and Product Surety processes across BMS and external partners--- Support Serialization and Product Surety process alignment with evolving regulations--- Maintain global expertise through ongoing training and participation in industry forums--- Create and utilize metrics and KPIs to identify and assure Serialization and Product Surety programs' success and continuous improvement--- Provide data and input to drive other continuous improvement efforts across the enterprise as applicable--- Provide support to ensure continuity of Serialization and Product Surety process and support systems through major initiatives (e.g. integration, divestiture, or reorganization); serve on program teams or sub-teams, manage interim state of operations, support establishment of defined future state of processes, as applicable--- Maintain awareness of Culture of Excellence across BMS and adherence to BMS core behaviors--- Provide support for project teams and committees related to Serialization and Product Surety--- Required travel approximately 25% to ensure Serialization and Product Surety processes are globally deployed in an effective and inclusive mannerRequired Knowledge/Skills/QualificationsEducation: Bachelor of Science degree e.g., Pharmacy, Chemistry, Biology, Engineering.Experience/Knowledge: --- A minimum of 8-12 years of experience in pharmaceutical industry--- Thorough understanding of company policies and regulatory requirements, and provide subject matter expertise in their relation to Serialization and Product Surety--- Familiar with electronic quality system tools--- Strong program and project management experience with proven track-record of several years supporting cross-functional programs and ability to manage multiple, simultaneous projects, preferably in Quality--- Mastery of relevant Quality compliance processes and regulations--- A minimum of 3-5 years of pharmaceutical operations, regulatory, or other relevant biopharmaceutical industry experience--- Understanding of technical areas related to pharmaceutical and/or biological manufacturingSkills/Competencies: --- 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--- Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)--- Project management experience and ability to focus on execution of strategic decisions while balance conflicting priorities--- Demonstrated 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 deadlines--- Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising complianceBristol-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 the resources to pursue their goals, both at work and in their personal lives.

Keywords: Bristol-Myers Squibb Company, New Brunswick , Manager, Global Quality Serialization and Product Surety, Executive , New Brunswick, New Jersey

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