Live opening · Posted 12 days ago

Sr. Project Manager

Excelra · Pune District, Maharashtra, India (On-site)
Linkedin No
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At a glance

The key details from the original listing.

Posted 12 days ago
CompanyExcelra
LocationPune District, Maharashtra, India (On-site)
Work modeNo
SourceLinkedin
Listed12 days ago

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About the role

Description supplied by the original job listing.

Key responsibilities
Own the integrated plan, budget, RAID log and governance cadence across a portfolio of R&D digital initiatives: Veeva Vault RIM implementation and QMS adoption, validation transformation, AI and ML enablement, and application managed services.
Lead the new Veeva RIM implementation with an India based team, and drive adoption uplift for the recently implemented QMS.
Run an independent review and harmonisation of validation SOPs across India and international sites, define a risk based CSA approach for SaaS platforms, and rationalise the contract validation resource base.
Support the build of an R&D data fabric and delivery of pluggable AI use cases across the R&D value chain.
Stand up a managed support model for the R&D application stack (ELN, LIMS, Veeva, chromatography data systems, standalone scientific software), including transition from the incumbent vendor and rationalisation of the application estate.
Manage the client relationship at senior level across business, quality, R&D IT and site leadership, and act as single point of accountability for delivery.
Manage platform vendors and third party partners against scope, milestones and quality commitments.
Build, mobilise and retain the onsite and offshore team, with visible skill retention at the R&D centre rather than churn through sub contracting.
Ensure deliverables meet GxP and data integrity expectations, with validation planned rather than retrofitted.
Provide clear status reporting and early escalation of risk.
Experience
Essential
12 to 15 years in pharmaceutical or life sciences IT, with at least 5 years managing multi workstream programmes end to end.
Delivery of at least one enterprise regulated platform implementation, ideally Veeva Vault (RIM or QMS).
Working knowledge of computerised system validation, CSA and data integrity requirements in a regulated R&D environment.
Experience standing up or transitioning application managed services for a scientific or R&D application stack.
Proven vendor and stakeholder management at senior client level.
Experience building and running distributed delivery teams in India.
Strong written and verbal communication; credible in front of R&D scientists, quality leadership and IT.
Desirable
Veeva RIM regulatory submissions exposure.
Familiarity with the R&D application landscape (ELN, LIMS, chromatography data systems) and adjacent tools such as DoE or predictive analytics platforms.
Experience replacing an incumbent managed services vendor.
PMP, PRINCE2 or equivalent certification; Agile delivery experience.

Work arrangement
No

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