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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.

Job Grade: EG-110

Job Profile: Sr. Specialist – Problem & Deviation Management

Location: Hyderabad, India

Sr. Specialist IT Problem and Deviation Management is a key role in an organization that utilizes ServiceNow & Veeva vault platforms for managing IT Quality Deviations and Problem management processes. The primary responsibility for this role is to conduct IT Quality Deviations and Problem investigations within the IT Enterprise domain. Works in a global, collaborative, diverse environment and be able to drive IT compliance while leveraging subject matter resources and capabilities. Collaborate with IT teams, business users and global quality teams to ensure problem and deviation investigations are executed in accordance with internal procedures. Work with one-up manager and peers to propose effective and efficient quality strategies for IT problem and deviation investigation management.

At BMS, digital innovation and Information Technology are central to our vision of transforming patients’ 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.

Key Responsibilities:

• Support the IT Investigation process owner with the creation and management of IT Deviations, Problems, and associated records such as Corrective and Preventive Actions(CAPAs) and Effectiveness checks.
• Create, define and support end-to-end processing of Problems and Deviations received on IT Enterprise applications.
• Perform IT Problem and Deviation Assessments and Root Cause Analysis, including scheduling and managing meetings with stakeholders to conduct IT Investigations.
• Train and coach other members on performing IT Problem and Deviation investigations and their related process and procedures.
• Gather metrics and generate reports (from Veeva & IT ServiceNow) to provide key insights for management on Problems, Deviations and Actions.
• Stay abreast of external trends and benchmark to seek continuous improvement opportunities for the Problems and Deviation Management process.
• Assist in creating and/or revising SOPs, WIs, and Job-Aids governing IT Investigations process (both problem and deviation management).
• Assist in providing IT Problem and Deviation management metrics to IT Quality Councils.
• Drive process improvements to enhance IT Problem and Deviation management process (e.g.  new technology and simplification).
• Solve variety of problems and analyze possible solutions within guideline.
• Support the IT Investigation process center of excellence meetings with stakeholders.
• Understand and adhere to established procedures (SOPs, WI, Policies)
• Provide thought partnership on health authority inspection and audit support. Working with ITQA (Global Quality), facilitate inspection readiness, requests for information/documentation, and inspection response activities for IT functions and enterprise computer systems. 

Qualifications and Requirements:

• 4 to 6 years’ experience is required preferably in the Pharmaceutical or Biotech industry.
• Knowledge of and experience with applying health authority regulations (Computer System Validation, 21 CFR Part 11/Annex 11, Data Integrity, Industry Guidelines etc.).
• End-to-end GxP Quality Deviation Management experience is required with the ability to process Deviations and associated records in a QMS System (Veeva, Trackwise etc.).
• Previous experience in Root Cause Analysis (RCA) and implementation of CAPAs in regulated industry.
• Knowledge of Quality QMS modules (Deviations, Actions and Change modules) and ITSM principles (Incident, Problems, Asset Management).
• Experience leading and driving multidisciplinary work groups or teams to meet objective of the team and department.
• Must be able to influence leaders and stakeholders to drive sound solution for IT deviation investigations and CAPAs.
• Good understanding of data visualization of incidents, problems, deviations and actions.
• Must be an effective communicator, both verbal and written, with the ability to organize and present ideas in a convincing and compelling manner.
• Must be self-directed with proven ability to make mature decisions supported thorough data analysis.
• Good analytical and interpersonal skills 

Education: Bachelor’s degree in Sciences or Engineering is preferred

If you come across a role that intrigues you but doesn’t 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 “Transforming patients’ lives through science™ ”, 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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 [email protected]. Visit careers.bms.com/eeo-accessibility 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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