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. 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.
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Functional and Technical
- QA Review and approval of validation deliverables associated with various BMS enterprise systems including but not limited to clinical study databases electronic Case Report Forms (eCRF), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, and various VEEVA Vault based configurations.
- Ensure adequate and timely quality assurance / regulatory compliance support
- Provide support during regulatory agency and third party inspections
- Research new technologies, understand existing processes, and reference recognized standards and frameworks
- Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education.
- Identify opportunities for continuous improvement
- Adherence to BMS Core Behaviors
- Conduct risk & impact assessment to determine the extent of validation and qualification and ensure right sized validation effort for programs
- Demonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systems
- Implement organizational IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirements
- Review Periodic Review assignments completions for applications in a timely manner
- Support responses to application CAPAs and Audits as they relate to health authority investigations and internal audits in a timely manner-in coordination with multiple stakeholder teams
Qualifications & Experience
- B.E./B.Tech. or equivalent in computer science, engineering, life science field
- A minimum of 5-7 years of experience in Quality Assurance, IT Compliance and computer systems validation (CSV) in the pharmaceutical industry, including at least 3 years of managing/overseeing IT Compliance and CSV projects
- Candidate must have a strong understanding of 21 CFR Part 11, EU Annex 11, Data Integrity principles, GAMP and Agile methodologies. Additionally, good understanding of Computer Software Assurance principles desired.
- Understanding of quality risk-management concepts (ICH Q9) preferred
- Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures
- Previous experience as a computer system validation / quality assurance / quality control analyst for a life sciences company regulated by the FDA (or equivalent) preferred
- Familiarity with the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes
- Experience with driving validation strategies across across the end-to-end product lifecycle as well as experience with widely used IT Enterprise platforms (SAP, Veeva, ServiceNOW etc.)
- General knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, IaaS as well as networks, operating systems, databases, and software tools
- Candidate must have strong knowledge of IT testing practices and methodologies in the pharmaceutical GxP space-and good working knowledge of tools like ALM and Valgensis
- Ability to make decisions that impact own work and other groups/teams and works with minimal supervision
- Ability to support various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team
- Demonstrates openness to learning and developing. Takes a responsibility for their own and team’s development and growth
- Demonstrates an understanding of factors driving team performance and how they contribute to the team's overall success
- Strong sense of ethics, diplomacy and discretion
- Commitment to Quality
- Fluent in English, with proven professional working proficiency in English for reading, writing and speaking. including the ability to deliver clear and articulate presentations
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 a supportive culture, promoting global participation 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 an 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 adastaffingsupport@bms.com. 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/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
