Manager Global Quality Serialization and Product Surety

Profile

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, within the Global Product Quality Complaint (PQC) group . 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 10 - 15% 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 6-10 years of experience in pharmaceutical industry

Experience working within Product Quality Complaint (PQC) highly desired.

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:

GMP and Quality knowledge, particularly in the area of Product Quality Complaint handling.

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. Company: Bristol-Myers Squibb Req Number: R1521890_EN Updated: 2020-02-20 00:00:00.000 UTC Location: New Brunswick,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com