Project Lead — GxP Software Implementation

Role: Project Lead — GxP Software Implementation

Location: Bangalore / Remote

Organization: Digital, Data & IT (DDIT), Research & Development (R&D)

Business area: Healthcare

Role purpose

Lead the end-to-end implementation of software solutions used in a GxP-regulated R&D environment. The Project Lead brings business, scientific, quality, technology, and supplier teams together to deliver a fit-for-purpose solution that meets user needs, is appropriately validated, protects data integrity, and is ready for controlled operation.

The role is accountable for delivery against agreed scope, schedule, budget, quality, and adoption objectives. It ensures that GxP considerations are built into planning and execution from the outset, in partnership with the relevant process owners and Quality functions.

Required qualifications and experience

• Bachelor’s degree or equivalent practical experience in information technology, engineering, life sciences, business, or a related discipline.
• Demonstrated experience leading complex software implementation or transformation projects, preferably in a regulated life-sciences, pharmaceutical, biotechnology, medical-device, or comparable environment.
• Practical understanding of GxP computerized systems and the quality practices used to deliver and maintain them, including risk assessment, documented requirements, testing, change control, and lifecycle
• documentation.
• Experience coordinating multidisciplinary teams and external suppliers, with accountability for scope, schedule, budget, risks, and delivery outcomes.
• Strong stakeholder-management, facilitation, written communication, and presentation skills.
• Ability to make complex work understandable, bring structure to ambiguity, and maintain delivery momentum while protecting quality and compliance.
• Proficiency with common project planning, collaboration, and reporting tools.
• Professional fluency in English; additional languages may be beneficial depending on the project’s stakeholder and user community.