Posted in General Business 30+ days ago.
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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:
This position is responsible for implementing and managing Celgene’s GMP Data Governance and Data Integrity program at the Warren, NJ site for the CAR T development facility. This includes implementing documentation and processes in support of the laboratories, manufacturing and GMP support areas.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
· Must have expert GMP, Quality, and Data Integrity knowledge;
· Must be able to effectively interpret problems and communicate in an impactful manner to management and the group with clarity and a high level of accuracy;
· Must be able to note data integrity attributes in potential situations or issues and process science based solutions across a majority of the job function;
· Must provide guidance to other employees in the interpretation of data integrity issues; across the Summit and Warren, NJ sites;
· Must be able to critically review reports while effectively inputting and expressing Data Integrity principles;
· Completes routine tasks with no supervision; Confident in making decisions in their subject matter area; Able to work proactively. Drives continuous improvement and improves efficiency and productivity within the group or project;
· Leads cross functional project teams driving performance and results. Skilled at getting resources and information from internal and external contacts;
· Manages conflict and issues with internal and external customers. Able to recognize conflict and notify management with proposed recommendations for resolution;
· Builds and leverages relationships and provides advice internally within function and with global cross-functional teams. Negotiates solutions cross functionally;
DUTIES AND RESPONSIBILITIES:
EDUCATION AND EXPERIENCE:
Bachelor’s degree preferred OR an equivalent combination of education and experience acceptable;
· Minimum 6 years relevant work experience with at least 3 years focused in Data Integrity and a minimum 2 years of leadership or cross-functional leadership experience required;
Regulatory Audit Experience is Highly Preferred.
· Experience with PC based office computers and standard Microsoft Office applications;
· Experience with SharePoint;
· Experience with electronic document and data management systems
WORKING CONDITIONS: (US Only): ENVIRONMENTAL CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
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 the resources to pursue their goals, both at work and in their personal lives.