Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


Bristol Myers Squibb

Senior Manager, IT Validation Services, GPS and Research

Science and Research

Research Manager

Yearly

No

New Brunswick, New Jersey, United States

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 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.

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 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 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 8-10 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.

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. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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