About the role
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.
Key Responsibilities
- Provide operational leadership and manage a team responsible for computer system validation, QC Systems and IT problem and deviation management
- Oversee and coordinate resource activities related to PDS enterprise Functions ensuring technology systems are designed and fit for their intended use in accordance with industry best practices and regulatory requirements.
- Develop, implement, and continuously improve quality, technical services and CSV processes.
Liaise with the Functional Leads of Computer System Validation, Quality servicesQC Systems, Global technical Technical services Services and Problem and Deviation management to ensure that initiatives are aligned across departments and that best practices are consistently followed. - Foster strong relationships with cross-functional teams, vendors, and stakeholders to ensure smooth execution of data governance strategies.
- Ensure the team’s alignment with organizational objectives by setting performance metrics and providing continuous feedback and coaching.
- Monitor vendor performance, including resources assigned by the vendor, ensuring service level agreements (SLAs) are met and any issues are addressed in a timely manner.
- Collaborate with senior leadership to define and implement strategies that support business needs.
- Prepare and present regular reports on quality and validation initiatives to leadership, including progress updates, risks, and areas for improvement.
People and Vendor Management Skills:
- Proven ability to manage, lead, and motivate teams of varying sizes, ensuring team cohesion and high performance.
- Experience in managing vendors and third-party relationships, ensuring alignment with organizational objectives and performance standards.
- Strong communication skills to manage both internal and external stakeholder expectations.
- Ability to foster a culture of collaboration, accountability, and continuous improvement.
- Experience in managing cross-functional teams and projects, ensuring alignment with strategic
objectives. - Demonstrated experience in managing team budgets and resource allocation including Standard Leader Work.
Qualifications & Experience
- B.E./B.Tech. or equivalent in computer science, data science, business administration, or related field (Master’s preferred).
- 12+ years of experience in computer system validation in the life sciences with at least 4 years in a leadership role.
- Strong understanding of data governance frameworks, data quality standards, and regulatory requirements (e.g.,21 CFR Part 210, 211, 58, 312, 50, 56).
- Experience with Computer System Validation (CSV) and familiarity with industry standards (21 CFR Part 11.
- 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 .
- Experience with large, enterprise, regulated systems such as CMMS, and LIMS.
- IT Problem and Deviation management.
- Proven track record in people management, including team development, coaching, and performance management.
- Experience managing vendor contracts and relationships.
- Knowledge of data management tools, systems, and platforms (e.g., database systems, data quality tools, reporting platforms).
- Strong project management skills, with experience overseeing multiple projects simultaneously.
- Fluent in English, with proven professional working proficiency in English for reading, writing and speaking, with the ability to present complex ideas to senior leaders.
- 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.
- 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 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 Valgenesis.
- 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 responsibilityresponsibility 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
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1603309 : Associate Director PDS BI&T Enterprise Functions India leadAplyr's read
Bristol-Myers Squibb is a leader in biopharmaceutical innovation, attracting professionals dedicated to advancing treatments for serious diseases worldwide.
What's promising
- •Strong pipeline of innovative drugs targeting serious diseases like cancer and cardiovascular conditions.
- •Global presence offers diverse career opportunities across multiple therapeutic areas.
- •Commitment to research and development with significant investment in cutting-edge technologies.
What to watch
- •High dependency on a few blockbuster drugs for revenue.
- •Regulatory challenges can delay drug approvals and market entry.
- •Competitive pressure from other pharmaceutical giants in oncology and immunology.
Why Bristol-Myers Squibb
- •Focus on precision medicine and personalized healthcare solutions.
- •Robust collaborations with academic institutions and biotech firms enhance research capabilities.
- •Pioneering work in cell therapy, particularly in oncology, sets it apart.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Bristol-Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for patients with serious diseases.
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