Bristol Myers Squibb IT Quality Management in New Brunswick, New Jersey

Lead and manage Computer System Validation (CSV) and qualification efforts for systems used across multiple functional business organizations focusing on Data Management and Data Lake capabilities supporting regulated processes. Supervise full time staff and contractors assigned to CSV projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures. Collaborate with Build & Run teams, business users and internal Global Quality compliance staff to ensure that CSV activities are planned and executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies for implementation of data lakes and related technology solutions. Refine and standardize SDLC and CSV processes for continuous improvement. Evaluate, propose and implement technology solutions that improve digitization, compliance and productivity. Serve as a CSV subject-matter-expert in support of internal and external regulatory inspections. Collaborate with peers across BMS on procedures relating to quality, data integrity and computer system validation.

Responsibilities

  • Oversees & executes CSV & QA activities for IT capabilities to ensure 'fit for use' before release to production environment

  • Collaborates and works closely with Data Architecture and Enterprise Architecture teams to ensure alignment of principles while identifying opportunities for improvement

  • Ensures adherence to software development practices, compliance, and key IT controls

  • Identifies opportunities for simplification and partners with Build & Run teams to implement

  • Supports Inspections and audits (internal and external)

  • Performs and provides direction on data analytics to understand risk and impact

  • Applies understanding of key business drivers to accomplish own work and influence work on peers

  • Interprets business and industry challenges and recommends best practices-based solutions to improve products, processes, systems

  • Implementation of IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirements

  • QA representative in problem management and audit remediation activities

Skills & Requirements:

  • B.S. or equivalent in computer science, engineering, life science or related field.

  • A minimum of 10 years’ experience in computer systems validation in the pharmaceutical industry (development of CSV deliverables, execution of software testing, etc, data management, data integrity concepts), including at least 2+ years managing/overseeing CSV projects.

  • Candidate must be a subject matter expert in computer system validation, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines.

  • Candidate must be technically conversant in concepts and techniques related to software development and data management.

  • Demonstrated ability to manage staff including workload and career development.

  • Demonstrated ability to plan and organize effectively across multiple projects and tasks.

  • Demonstrated ability to influence, collaborate, and communicate directly at various organizational levels.

  • Strong oral and written communication skills including the ability to write superior documentation and deliver clear and articulate presentations.

  • Open to creative, innovative, flexible and practical approaches to improving practices and solving problems.

  • Ability to analyze workflows, processes, and evolving database trends in order to deploy new system architecture.

  • Experience in Agile software development methodologies.

  • Basic knowledge of AWS Big Data Platforms, data warehousing and integrations technologies a plus.

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, disability or protected veteran status.