Full Job Description
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients' lives through science. At the core of that mission are the talented individuals who contribute their "unique" skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team. What unique gene will you bring?
The ITQM CSV Manager, GPS and Research will, lead and manage Computer System Validation (CSV) and qualification efforts for systems used across multiple functional business organizations focusing supporting regulated processes within the GPS and Research space.
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 the IT Delivery Team, 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 GxP 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.
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 the IT Delivery Team 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 andinfluence 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 of8-10 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 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 the resources to pursue their goals, both at work and in their personal lives.