Artificial Intelligence & Engineering
AI & Engineering leverages cutting-edge engineering capabilities to help build, deploy, and operate integrated/verticalized sector solutions in software, data, AI, network, and hybrid cloud infrastructure. These insights are powered by engineering for business advantage, helping transform mission-critical operations.
Join our AI & Engineering team to help transform technology platforms, driving innovation, and help make a significant impact on our clients' achievements. You’ll work alongside talented professionals reimagining and re-engineering operations and processes that could be critical to businesses.
As a Manager at Deloitte Consulting, you will large scale tech and AI transformation programs across the R&D spectrum for leading Life Sciences players, which may involve end-to-end delivery for AMS Operate engagements and implementation and configuration of critical R&D applications (Veeva Vault suite, Planisware, Argus, etc.) — spanning Clinical, Regulatory, Quality, Safety, Early Phase and Development, and Medical Affairs application domains. You will serve as the primary client relationship owner and delivery accountable, combining deep R&D domain expertise, hands-on configuration and integration expertise, AMS operational excellence, and strategic thinking to translate complex business and operational challenges into structured, scalable, and compliant technology solutions. This role is central to Deloitte’s growing Life Sciences R&D Managed Services practice, responsible for sustaining and evolving mission-critical R&D platforms at scale.
Work you'll do
- Lead large scale technology implementation and transformation programs for large pharmaceutical companies across their R&D spectrum
- Translate business strategy into a multi-year tech roadmap, aligned to drug discovery, pre-clinical, clinical, and regulatory goals
- Lead cross-functional global teams, establish governance, risk management, escalation processes, and executive reporting
- Ensure Computerized system validation (where applicable), audit readiness, data integrity, GxP compliance, risk assessments, change control, etc.
- Own the ITSM service management framework for Application Management and Support engagements, encompassing Incident Management, Problem Management, Change Management, and Service Request Management across all supported platforms.
- Serve as the primary escalation point for complex L2/L3 incidents and major operational issues; drive structured resolution with appropriate client communication and post-incident review.
- Govern SLA performance, KPIs, and operational metrics across the AMS portfolio; prepare and present executive-level operational reports and steering committee presentations.
- Oversee Change Management governance including CAB (Change Advisory Board) leadership, change risk assessment, and post-implementation review programmes.
- Manage ServiceNow and JIRA platform governance, including dashboard design, reporting configuration, and tool administration oversight.
- Drive continuous service improvement and automation initiatives across the portfolio, quantifying efficiency gains and building improvement roadmaps.
- Enforce GxP and applicable compliance standards across all engagement activities — implementation, configuration, and AMS operations — including 21 CFR Part 11, EU Annex 11, ICH E6 GCP, ICH M8 eCTD, ISO 9001/13485, GMP/GLP requirements, OPDP/MHRA promotional guidelines, and PhRMA/EFPIA codes of practice, as applicable to each platform and domain in scope.
- Ensure audit trail integrity, data integrity controls, and regulatory adherence are embedded in all service delivery and implementation processes.
- Lead engagement-level preparation for regulatory inspections and GxP IT audits; act as the primary Deloitte interface during client audit events.
- Review and approve engagement-level documentation including governance frameworks, SOPs, solution design documents, and change management records.
- Lead R&D platform advisory and roadmap discussions with senior client stakeholders, aligning scope and capabilities to evolving R&D technology strategies across Clinical, Regulatory, Quality, Safety, and Medical Affairs domains.
- Oversee the transition of new R&D platform implementations and upgrades into steady-state operations, including knowledge transfer, run-book development, and hyper-care management to ensure service continuity and operational readiness.
- Drive adoption of intelligent automation, AI-assisted monitoring, and analytics capabilities
The team
You will play a key role in delivering and evolving verticalized Managed Services solutions tailored to the unique needs of Life Sciences R&D clients across Clinical, Regulatory, Quality, Safety, and Medical Affairs. In this role, you will help transform how organizations run and sustain mission-critical operations by combining specialized talent, standardized delivery models, and advanced technology. You will support clients in improving service delivery, driving operational efficiency, maintaining compliance, and enabling scalable growth in a dynamic and highly regulated environment.
Location: Bengaluru/Hyderabad/Pune
Qualifications
Required:
- 10+ years of experience in Life Sciences IT, with significant hands-on experience in configuration, integration, and AMS / Operate delivery across R&D application domains (Clinical, Regulatory, Quality, Safety, and/or Medical Affairs), including at least 3 years in a management or delivery leadership role.
Proven track record leading complex Life Sciences R&D technology engagements across two or more of the following domains: Clinical (e.g. CTMS, EDC, eTMF, study management), Regulatory (e.g. RIM, eCTD, submissions), Quality (e.g. QMS, LMS, document management), Safety (e.g. pharmacovigilance, safety reporting, Argus), or Medical Affairs — with strong emphasis on platform configuration, system integration, and AMS Operate delivery.
Demonstrated ability to lead delivery governance across multiple workstreams, with accountability for scope, service quality, financial performance, and client outcomes.
Some expertise in ITSM processes, including Incident, Problem, Change, and Service Request Management, within GxP-regulated environments.
Experience overseeing Life Sciences platform implementations, including solution design governance, transition to support, hyper-care management, and go-live readiness across R&D domains.
Strong proficiency in ServiceNow for ITSM governance, SLA/KPI management, and operational reporting, as well as JIRA for Agile delivery management and cross-functional coordination.
Comprehensive understanding of GxP requirements for Life Sciences R&D systems, including 21 CFR Part 11, Annex 11, ICH E6 GCP, and other relevant ICH guidelines.
Proven track record of building, leading, and developing cross-functional onsite/offshore teams within a global delivery model.
Demonstrated ability to manage senior client and executive stakeholder relationships, define and govern SLAs, and drive service performance against contractual commitments.
Experience managing engagement financials, including budgeting, forecasting, revenue/margin oversight, and overall commercial performance.
Strong leadership, communication, and stakeholder management skills, with the ability to communicate complex delivery and operational topics clearly to senior and executive audiences.
Experience defining and executing continuous service improvement initiatives and automation roadmaps across managed services environments.
Excellent documentation skills across governance artifacts, operating procedures, solution and support documentation, SLA dashboards, and executive-level reporting.
Preferred:
- Veeva Vault certification
- PMP (Project Management Professional) or PRINCE2 Practitioner certification.
- ITIL Expert or ITIL v4 Managing Professional certification.
- SAFe Agile or equivalent scaled Agile delivery certification.
- Broad platform familiarity across Life Sciences R&D domains, including clinical (e.g. Medidata Rave, Vault Clinical, Oracle Clinical One, Planisware, SAS Grid), regulatory (e.g. Veeva Vault, Lorenz Docubridge, PRISM, Documentum), quality (e.g. MasterControl, Veeva Vault Quality, ComplianceWire, ALVIS LMS), and medical affairs (e.g. Veeva Vault MedInquiry, IRMS Anju (Admin, Web, DV, CM), Wordpress, Drupal medical websites), Safety (Argus Safety)
- Experience with cloud-hosted Life Sciences platforms and GxP cloud compliance frameworks (AWS, Azure, GCP).
- Knowledge of Life Sciences industry trends including digital R&D transformation, AI/ML in drug development, and regulatory technology evolution.
- Experience in regulatory inspection readiness and support for GxP IT audits.
- Lean Six Sigma or equivalent process improvement certification.
- MBA or advanced postgraduate degree is a plus.
- BE / B.Tech / M.C.A. / M.Sc (CS) or MBA / equivalent postgraduate degree from an accredited university.
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