Key responsibilities

Project leadership and delivery

Define the project charter, objectives, scope, deliverables, governance,

milestones, resource plan, budget, and measures of success.

Lead implementation through the appropriate delivery lifecycle, coordinating discovery, design, configuration or development, testing, deployment, and transition to operations.

Maintain an integrated project plan and manage dependencies, risks, issues,

decisions, assumptions, and changes.

Facilitate timely decisions; escalate material risks and delivery constraints with clear options and recommendations.

Provide concise, accurate status reporting to project governance and stakeholders.

Coordinate internal teams, implementation partners, and software vendors,

clarifying accountabilities and deliverables across organizational boundaries.

GxP quality and compliance

Integrate applicable GxP, quality-system, data-integrity, privacy,

cybersecurity, and records-management requirements into project planning and solution delivery.

Partner with process owners, system owners, Quality, validation, security,

privacy, architecture, and operations representatives to establish the required compliance approach.

Ensure that intended use, user and system requirements, risk assessments,

traceability, testing evidence, and release documentation are developed and maintained as appropriate to the system and its risk.

Coordinate validation or other documented assurance activities in line with applicable procedures and the agreed risk-based approach.

Support controlled configuration and change management, including assessment of changes that could affect validated state or regulated processes.

Ensure readiness for deployment, including training, procedures, support model, data migration where applicable, and transition into a controlled operating environment.

Promote inspection readiness through complete, consistent, and retrievable project documentation; support audits or inspections as requested.

Stakeholder engagement and change adoption

Translate R&D; business and user needs into clear scope,



outcomes, and prioritized requirements with accountable stakeholders.

Build alignment across global and local teams, including users, product or process owners, technical teams, and quality partners.

Communicate project impacts, decisions, risks, and readiness expectations in a timely and audience-appropriate way.

Coordinate change-impact assessment, stakeholder engagement,

communications, and role-based training with the relevant change and business leads.

Gather feedback and support a smooth handover so that the solution can be sustainably operated and continuously improved.

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.

Robust 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.

Preferred qualifications and experience

Experience implementing software that supports R&D; processes, such as laboratory, clinical, scientific-data, quality, or research information systems.

Relevant project-management training or certification, or demonstrated equivalent experience.

Familiarity with agile, waterfall, or hybrid delivery approaches and the ability to select practices appropriate to project risk and context.

Experience with system integration, data migration, SaaS or cloud delivery,

supplier oversight, or global rollouts.

Experience supporting computer-system validation or risk-based assurance activities in collaboration with Quality and system owners.

Understanding of data integrity principles and the controls needed to support reliable, attributable, and traceable records.

Capabilities for success

Accountable delivery: Turns objectives into a realistic plan and follows through on commitments.

Quality-minded judgment: Treats compliance and patient- and product-

relevant risk as integral to delivery, not as a final checkpoint.

Influence without authority: Builds trust and alignment across functions,

regions, and partner organizations.

Clear communication: Makes progress, trade-offs, and decisions visible without obscuring important detail.

Pragmatic problem-solving: Resolves obstacles with proportionate,

evidence-based actions and escalates when needed.

User-centered change leadership: Keeps the intended users and operational context in view from requirements through adoption.

Continuous improvement: Captures lessons learned and applies them to improve delivery and operational readiness.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Project Lead - GXP Software (Bengaluru)
🏢 Redolent
📍 Bengaluru