Bristol-Myers Squibb
Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead
Bristol-Myers Squibb, Indianapolis, Indiana, us, 46262
Senior Manager, IT - GxP Computer Systems Validation & IT Process Lead
Working with UsChallenging. 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 rich in diversity. 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.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. You will work with lab & process automation, large corporate systems, small biotech systems, across all functions for the Indianapolis site(s). Additional responsibilities will include establishing and ensuring appropriate IT policies and processes while working with IT partners and specialty equipment manufacturers to achieve our technology and commercialization goals.*This position is located at Rayzebio's Indianapolis, IN site*Key Responsibilities:Ensure complete understanding of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies.Draft and review of Computer System 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.Change Management during qualification and sustaining.Education and Experience/Skills:Bachelors in Engineering, IT, Science field or equivalentMinimum 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.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.
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Working with UsChallenging. 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 rich in diversity. 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.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. You will work with lab & process automation, large corporate systems, small biotech systems, across all functions for the Indianapolis site(s). Additional responsibilities will include establishing and ensuring appropriate IT policies and processes while working with IT partners and specialty equipment manufacturers to achieve our technology and commercialization goals.*This position is located at Rayzebio's Indianapolis, IN site*Key Responsibilities:Ensure complete understanding of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies.Draft and review of Computer System 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.Change Management during qualification and sustaining.Education and Experience/Skills:Bachelors in Engineering, IT, Science field or equivalentMinimum 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.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.
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