WORKING WITH US Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us

DESCRIPTION:

Executes Computer System Validation (CSV) and qualification efforts for systems used across multiple functional business organizations focusing on supporting regulated processes within the GPS and Research space. Executes 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 implement effective and efficient quality strategies for implementation GXP related technology solutions. Refine and standardize SDLC and CSV processes for continuous improvement. Implement technology solutions that improve digitization, compliance and productivity. Support CSV related internal and external regulatory inspections. Collaborate with peers across BMS on procedures relating to quality, data integrity and computer system validation.

RESPONSIBILITIES:

• Oversees and executes CSV & QA activities for IT capabilities to ensure 'fit for use' before release to production environments
• Ensures adherence to software development practices, compliance, and key IT controls
• Identifies opportunities for simplification and partners with the IT Delivery Team to implement those opportunities
• Supports Inspections and audits (internal and external)
• 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
• Lead the execution of the Periodic Review Program to ensure existing capabilities remain in a state of control

SKILLS & REQUIREMENTS:

• B.S. or equivalent in computer science, engineering, life science or related field preferred.
• A minimum of 1 to 5 years’ experience in computer systems validation in the pharmaceutical industry (development of CSV deliverables, execution of software testing, etc, data management, data integrity concepts).
• Knowledgeable in CSV, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines.
• Knowledgeable in software development and data management principles.
• Demonstrated ability to execute and organize effectively across multiple projects and tasks.
• Demonstrated ability to influence, collaborate, and communicate directly with stakeholders.
• 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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, hematology, immunology, cardiovascular, fibrosis and neuroscience. Our employees work every day to transform patients’ lives through science.