Bristol Myers Squibb
AssociateDirectorPDSBI&TEnterpriseFunctionsIndialead
“Associate Director PDS BI&T Enterprise Functions India lead at Bristol Myers Squibb. Skills: Computer system validation, People management, Vendor management, Data governance. Provide operational leadership. Manage a team”
Industry & Context.
Solve problems
What They're Looking For.
Must Have
12+ years of experience in computer system validation, 4 years in a leadership role, Experience with Computer System Validation (CSV), Understanding of 21 CFR Part 11, Understanding of EU Annex 11, Understanding of Data Integrity principles, Understanding of GAMP, Understanding of Agile methodologies, Experience with large, enterprise, regulated systems, IT Problem and Deviation management, Proven track record in people management, Experience managing vendor contracts, Project management skills, Fluent in English, Experience in the interpretation and understanding of GxPs, Experience driving validation strategies, Experience with widely used IT Enterprise platforms, General knowledge of IT applications, General knowledge of IT infrastructure, General knowledge of architecture of computer systems, General knowledge of networks, General knowledge of operating systems, General knowledge of databases, General knowledge of software tools, Knowledge of IT testing practices, Knowledge of IT testing methodologies, Good working knowledge of ALM, Good working knowledge of Valgenesis, Ability to make decisions, Ability to support various projects, Ability to create and work within internal timeliness, Ability to solve problems, Ability to deliver on commitments, Ability to utilize interpersonal skills
Nice to Have
Master's preferred, Good understanding of Computer Software Assurance principles, Understanding of quality risk-management concepts (ICH Q9)
What You'll Do.
Provide operational leadership
Oversee computer system validation
Manage IT problem management
Manage deviation management
Coordinate resource activities
Ensure technology systems are designed
Ensure technology systems are fit for use
Develop quality processes
Implement quality processes
Improve quality processes
Develop technical services processes
Implement technical services processes
Improve technical services processes
Develop CSV processes
Implement CSV processes
Improve CSV processes
Liaise with Functional Leads
Ensure initiatives are aligned
Ensure best practices are followed
Foster relationships with cross-functional teams
Foster relationships with vendors
Foster relationships with stakeholders
Ensure smooth execution of data governance
Set performance metrics
Provide continuous feedback
Monitor vendor performance
Address vendor issues
Collaborate with senior leadership
Prepare reports on quality initiatives
Prepare reports on validation initiatives
Present progress updates
Present areas for improvement
How You'll Work.
Team & Collaboration
Cross-functional teams; Vendors; Stakeholders; Senior leadership
Communication Scope
Present complex ideas
Process & Methodology
Project management, Agile methodologies
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