Manager IT Quality ManagementCSV Operations Commercial amp EF

Profile

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 whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. ?Driven to make a difference, from innovative research to hands-on community support. ?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.

Lead and manage Computer System Validation (CSV) and qualification efforts for systems used across multiple functional business organizations focusing on ERP, Enabling Functions and Commercial capabilities supporting regulated processes.? Executes CSV projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures.? 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 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 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 Enterprise Architecture and Platforms; IT for Business Applications 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 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





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.

Basic knowledge and experience with working on large platforms is 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.

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.

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