Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t 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\xe2\x80\x99ll 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: .

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

Position Summary

Manage Computer System Validation (CSV) efforts for systems and applications in pharmaceutical GxP space. Supervise junior team members assigned to CSV projects to ensure effectiveness, efficiency, consistency, quality of work and compliance with external regulations and internal procedures.

Collaborate with cross functional and multi-location IT Delivery teams, business users and IT Quality 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.

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

At BMS, digital innovation and Information Technology are central to our vision of transforming patients\xe2\x80\x99 lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology. We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care.

If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!

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Key Responsibilities

Functional and Technical

• Perform Validation activities as it relates to applications used in multiple GxP business functions
• Perform/Oversee Qualification activities as it relates to infrastructure applications and hardware in a timely manner
• Conduct risk & impact assessment to determine the extent of validation and qualification
• Demonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systems
• Implementation of organizational IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirements
• Author/Review CSV deliverables including but not limited to Plans & Summary Reports
• Review and approve change tickets for applications and hardware in a timely manner to ensure alignment with the organization change management processes
• Support the SDLC process as it relates to application validation and infrastructure qualification
• Complete Periodic Review assignments for applications in a timely manner
• Support CAPAs and Audits as they relate to application and infrastructure investigations in a timely manner
• Plan training modules for team members and ensure training compliance for team members

People Management:

• Oversees and support CSV staff across defined GxP business unit applications to ensure \'fit for use\' before release to production environment
• Supervises CSV staff that includes a mix of employees and contractors
• Responsible for training and mentoring junior staff to meet BMS quality standards
• Preferred experience with working in a multi-cultural, multi-location and diverse environments

Qualifications & Experience

• B.E./B.Tech. or equivalent in computer science, engineering, life science field
• A minimum of 8-10 years of experience in computer systems validation in the pharmaceutical industry, including at least 3 years managing/overseeing CSV projects
• Good understanding (mandatory) of 21 CFR Part 11, EU Annex 11, Data Integrity principles, GAMP methodologies and Agile methodologies
• Experience with validation with one or more of the following systems (desirable): CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, eDC, Regulatory Submission systems
• General knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, IaaS as well as networks, operating systems, databases, and software tools
• Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of tools like ALM etc.
• Works predominately within established procedures. Ability to make decisions that impact own work and other groups/teams and works under minimal supervision
• Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth
• Demonstrates an understanding of factors driving team performance and how they contribute to the team\'s overall success
• Excellent English Oral and written communication skills including the ability to write documentation and deliver clear and articulate presentations

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 accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement

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If you come across a role that intrigues you but doesn\xe2\x80\x99t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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