Associate Director PDS BI&T Enterprise Functions India lead

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

Additional Information

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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