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Associate Director PDS BI&T Enterprise Functions India lead
On-site · Hyderabad, Telangana, India
Job Summary
Operational leadership and management of a team responsible for computer system validation, QC Systems and IT problem and deviation management. Oversees and coordinates resources for PDS enterprise Functions to ensure technology systems are fit for their intended use; develops and improves quality, technical services, and CSV processes; liaises with Functional Leads to align initiatives; fosters cross-functional collaboration for data governance and data integrity; monitors vendor performance and SLA adherence; collaborates with senior leadership to define strategies and reports progress, risks, and improvement opportunities. Emphasizes leadership in people management, vendor relationships, budgets, and cross-functional execution; includes on-site protocol and a pathway for site-specific occupancy decisions.
Required Qualifications
- 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, EU Annex 11, Data Integrity principles, GAMP and Agile methodologies)
- 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 professional working proficiency in reading, writing and speaking
- Understanding of quality risk-management concepts (ICH Q9) preferred
- Proven experience in interpretation of GxPs for controlled management of electronic records and signatures
- Familiarity with drug development processes from discovery to regulatory filing
- Experience with driving validation strategies across end-to-end product lifecycle
- Experience with IT Enterprise platforms (SAP, Veeva, ServiceNOW)
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