Specialist Quality Systems Deviations Cell Therapy

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.

PURPOSE AND SCOPE OF POSITION :

The Specialist for Deviation Management for Cell Therapy Manufacturing is responsible for supporting the Deviation Process. In this role, the incumbent will support the business process owner for the Deviation module and the associated governing local procedures and supporting processes. This is a highly visible role with site responsibility and cross-functional influence that has impact on departmental performance and broad quality deviation management. The incumbent will support the deviation process subject matter expert across the site.

REQUIRED COMPETENCIES :

Knowledge, Skills, and Abilities:


Must have experience with cGMP manufacturing, Quality, and Compliance.
Must be able to critically evaluate deviations and generate technical conclusions consistent with Quality risk management principles.
Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues.
Must understand continuous improvement and be able improve the compliance and efficiency of the quality system.
Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.
Requires moderate direction to complete more complex tasks
Comfortable providing input/guidance to others within the department and across the organization in deviation technical writing.
Propose solutions for issues and work with management to resolve.
Comfortable providing training/guidance to system users as needed, and in instructor-led settings.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Able to support internal and health authority inspections of facility Education and Experience:
College or university degree preferred.
5 years of Quality Systems related experience in a GMP Regulated Environment.Experience working with Quality Systems (i.e. EQRMS, Documentum, Trackwise) is required.Strong Communications, Analytical, and Critical Thinking Skills/Proactive approach to solving problems are required.
An equivalent combination of education and experience may substitute DUTIES AND RESPONSIBILITIES:
Support the Deviation Process for all GMP activities and works with responsible cross functional areas ensure timely completion.
Support the Deviation Management Meetings, generate meeting minutes, follow up on action items and facilitate resolution when required
Provides end-user training on the Deviation process and system
Compiles applicable process metrics, identifies trends and escalates accordingly
Communicates effectively with cross functional stakeholders on matters related to the deviation management process
Supports Quality Systems harmonization efforts.
Performs other tasks as assignedBristol-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: R1522507_EN Updated: 2020-03-16 00:00:00.000 UTC Location: Summit,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.

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