Bristol Myers Squibb
Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead
Bristol Myers Squibb, Indianapolis, Indiana, us, 46262
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
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 with the resources to pursue their goals, both at work and in their personal lives.
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors.
The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio's innovative drug products to patients in need. In this role, you will report directly to the Exec. Director, IT and be responsible to deliver on compliance and risk management for digital processes to achieve commercialization objectives at the site.
Job Responsibilities
Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams. Ensure RayzeBio computer systems validated for intended use including Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, protocols. Liaises with cross-functional SMEs in developing and promulgating the computer system validation methodology for radiopharma. Participates actively with other groups to analyze and address process deficiencies. Work collaboratively with peers within various departments and Quality groups. Provides validation subject matter expertise (SME) in the Digital Plant environment and contributes to multi-function teams, advises personnel on validation matters, and defends their work before regulatory agencies and auditors. Provides CSV expertise and guidance. Responsible for compliance with local and global SOPs during qualification. Audit and Operational readiness for site. Ensure complete understanding of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies. Change Management during qualification and sustaining. Education and Experience/Skills:
Bachelors in Engineering, IT, Science field or equivalent Minimum 10+ year's relevant industry experience. Prior radiopharma experience is highly valued but not required. Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment. Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation and Historians. Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP. Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements. Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 and good documentation practices. Demonstrated success working in a high-performing, business results-driven environment. Physical Requirements:
Standard office environment coupled with GMP production and facility environment. Must be willing to wear personal protective equipment (PPE) as required. Must be comfortable working with radioactive materials. 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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Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams. Ensure RayzeBio computer systems validated for intended use including Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, protocols. Liaises with cross-functional SMEs in developing and promulgating the computer system validation methodology for radiopharma. Participates actively with other groups to analyze and address process deficiencies. Work collaboratively with peers within various departments and Quality groups. Provides validation subject matter expertise (SME) in the Digital Plant environment and contributes to multi-function teams, advises personnel on validation matters, and defends their work before regulatory agencies and auditors. Provides CSV expertise and guidance. Responsible for compliance with local and global SOPs during qualification. Audit and Operational readiness for site. Ensure complete understanding of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies. Change Management during qualification and sustaining. Education and Experience/Skills:
Bachelors in Engineering, IT, Science field or equivalent Minimum 10+ year's relevant industry experience. Prior radiopharma experience is highly valued but not required. Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment. Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation and Historians. Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP. Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements. Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 and good documentation practices. Demonstrated success working in a high-performing, business results-driven environment. Physical Requirements:
Standard office environment coupled with GMP production and facility environment. Must be willing to wear personal protective equipment (PPE) as required. Must be comfortable working with radioactive materials. 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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