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IT Quality Management, CSV Operations

Bristol-Myers Squibb

Location: Tampa, Florida
Type: Full-Time, Non-Remote
Posted on: October 28, 2020
This job is no longer available from the source.
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.
Lead and manage Computer System Validation (CSV) and qualification efforts for systems used across multiple functional business organizations supporting regulated processes. Supervise contractors assigned to CSV projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures. Collaborate with IT Delivery 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. 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
• Executes CSV & QA activities for IT capabilities to ensure 'fit for use' before release to production environment
• Ensures adherence to software development practices, compliance, and key IT controls
• Identifies opportunities for simplification and partners with IT Delivery 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
• 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 5-10 years’ experience in computer systems validation in the pharmaceutical industry (development of CSV deliverables, execution of software testing, data integrity concepts), including at least 2+ years managing 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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Job Type: Full time