(C-04+) Senior Manager, IT Quality Assurance-18130]

Job description
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 Responsibilities Functional 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 support Provide support during regulatory agency and third party inspections Research new technologies, understand existing processes, and reference recognized standards and frameworks Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education. Identify opportunities for continuous improvement Adherence to BMS Core Behaviors Conduct risk & impact assessment to determine the extent of validation and qualification and ensure right sized validation effort for programs Demonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systems Implement organizational IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirements Review Periodic Review assignments completions for applications in a timely manner Support 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 teams

Qualifications & Experience: B.E./B.Tech. or equivalent in computer science, engineering, life science field A 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 projects Candidate 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 Q+) preferred Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures Previous experience as a computer system validation / quality assurance / quality control analyst for a life sciences company regulated by the FDA (or equivalent) preferred Familiarity with the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes Experience 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 tools Candidate must have strong knowledge of IT testing practices and methodologies in the pharmaceutical GxP space-and good working knowledge of tools like ALM and Valgensis Ability to make decisions that impact own work and other groups/teams and works with minimal supervision Ability to support various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team Demonstrates openness to learning and developing. Takes a responsibility for their own and team’s development and growth Demonstrates an understanding of factors driving team performance and how they contribute to?the team's overall success Strong sense of ethics, diplomacy and discretion Commitment to Quality Fluent in English, with proven professional working proficiency in English for reading, writing and speaking. including the ability to deliver clear and articulate presentations