Job Title

About Bristol Myers Squibb:At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology, and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Key ResponsibilitiesFunctional and Technical:QA Review and approval of validation deliverables associated with various BMS enterprise systems including but not limited to clinical study databases electronic Case Report Forms (eCRF), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, and various VEEVA Vault based configurations. Ensure adequate and timely quality assurance / regulatory compliance supportProvide support during regulatory agency and third party inspectionsResearch new technologies, understand existing processes, and reference recognized standards and frameworksPursue continuous professional development through company paid internal/external training, certifications and/or continuing education.Identify opportunities for continuous improvementAdherence to BMS Core BehaviorsConduct risk & impact assessment to determine the extent of validation and qualification and ensure right sized validation effort for programsDemonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systemsImplement organizational IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirementsReview Periodic Review assignments completions for applications in a timely mannerSupport responses to application CAPAs and Audits as they relate to health authority investigations and internal audits in a timely manner-in coordination with multiple stakeholder teamsQualifications & Experience:B.E./B.Tech. or equivalent in computer science, engineering, life science fieldA minimum of 5-7 years of experience in Quality Assurance, IT Compliance and computer systems validation (CSV) in the pharmaceutical industry, including at least 3 years of managing/overseeing IT Compliance and CSV projectsCandidate must have a strong understanding of 21 CFR Part 11, EU Annex 11, Data Integrity principles, GAMP and Agile methodologies. Additionally, good understanding of Computer Software Assurance principles desired.Understanding of quality risk-management concepts (ICH Q9) preferredProven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signaturesPrevious experience as a computer system validation / quality assurance / quality control analyst for a life sciences company regulated by the FDA (or equivalent) preferredFamiliarity with the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processesExperience with driving validation strategies across across the end-to-end product lifecycle as well as experience with widely used IT Enterprise platforms (SAP, Veeva, ServiceNOW etc.)General knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, IaaS as well as networks, operating systems, databases, and software toolsCandidate must have strong knowledge of IT testing practices and methodologies in the pharmaceutical GxP space-and good working knowledge of tools like ALM and ValgensisAbility to make decisions that impact own work and other groups/teams and works with minimal supervisionAbility to support various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional teamDemonstrates openness to learning and developing. Takes a responsibility for their own and team’s development and growthDemonstrates an understanding of factors driving team performance and how they contribute to?the team's overall successStrong sense of ethics, diplomacy and discretionCommitment to QualityFluent in English, with proven professional working proficiency in English for reading, writing and speaking. including the ability to deliver clear and articulate presentations