Project Lead - GXP Software

Redolent; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Redolent in Bengaluru is seeking a senior Project Manager to lead complex software implementation programs in regulated life-sciences contexts. You will define charters, align stakeholders, and drive delivery across discovery, design, development, testing, deployment, and transition to operations.

You’ll manage integration with QA, validation, data integrity, privacy, and compliance, while maintaining governance, risks, and change-ready processes for sustainable operations.

Qualifications

• 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 in regulated life-sciences environments.
• Practical understanding of GxP computerized systems and related quality practices.
• Experience coordinating multidisciplinary teams and external suppliers with accountability for scope and delivery.
• Strong stakeholder-management, facilitation, written communication, and presentation skills.
• Proficiency with common project planning, collaboration, and reporting tools.
• Professional fluency in English; additional languages may be beneficial.

Responsibilities

• Project leadership and delivery across the full lifecycle.
• Define the project charter, objectives, scope, deliverables, governance, milestones, resource plan, budget, and success measures.
• Lead implementation through discovery, design, configuration/development, testing, deployment, and transition to operations.
• Maintain an integrated project plan and manage dependencies, risks, issues, decisions, assumptions, and changes.
• Facilitate timely decisions and escalate material risks with clear options and recommendations.
• Provide concise status reporting to governance and stakeholders.
• Coordinate internal teams, implementation partners, and software vendors across boundaries.

Skills

Project leadership

Stakeholder management

Delivery governance

Education

Bachelor's degree or equivalent practical experience in IT/eng/life sciences

Job description

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; escalated 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.
• 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.

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:

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

Pragmatic problem-solving:

• Pragmatic problem-solving: Resolves obstacles with proportionate, evidence-based actions and escalates when needed.

User-centered change leadership:

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

Continuous improvement:

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