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IT Project Manager

F. Hoffmann-La Roche Ltd
NewPosted today

LOCATION

Hyderabad · Hybrid

EXPERIENCE

Not specified

TYPE

FullTime

SKILLS REQUIRED

Project ManagementSCRUMRegulatory ComplianceRisk ManagementComputer System Validation

Job description

Overview

Project Manager / Scrum Master (CSV & Compliance) to drive end-to-end delivery of validated computerized system implementations, upgrades, and migrations, balancing traditional project governance, Scrum Master facilitation, and CSV/CSA oversight under GxP regulations.

What you'll do

  • Take ownership of clearly defined, less complex tasks, smaller projects, or initiatives, including validated system implementations, upgrades, and migrations.
  • Assist in outlining and documenting scope for larger projects, identifying key components including validation scope and GxP impact, and flag potential scope-affecting issues.
  • Support the management of minor scope changes, understanding their basic impact on delivery and validation status.
  • Maintain and refine the product backlog so validation and compliance activities are planned alongside functional work.
  • Contribute to product roadmaps or service improvement plans upon request.
  • Apply traditional project management governance to assigned initiatives, including planning, milestone tracking, risk and issue management, and status reporting.
  • Provide day-to-day oversight of deliverables, quality of work, and adherence to timelines and quality requirements.
  • Escalate deviations from scope or timeline early, with proposed options for resolution.
  • Facilitate Scrum events (sprint planning, daily stand-ups, reviews, and retrospectives) for technical engineering squads.
  • Coach the team on Agile practices, remove impediments, and foster continuous improvement.
  • Adapt Agile ways of working to a regulated environment so iterative delivery produces documented compliance evidence, for example by embedding validation tasks and acceptance criteria into the definition of done.
  • Provide hands-on oversight of Computer System Validation (CSV) and Computer Software Assurance (CSA) activities across the system lifecycle under GxP regulations.
  • Coordinate the creation, review, and approval of validation deliverables such as validation plans, risk assessments, requirements and traceability matrices, test strategies and test summary reports, and validation summary reports.
  • Independently analyze less complex delivery and compliance problems, identify root causes, and own problem-solving plans within scope.
  • Identify discrepancies, including gaps in validation documentation or traceability, question assumptions, and propose improvements.
  • Contribute to projects or workgroups within a specified area and support or lead moderate-size projects.
  • Identify minor process improvement opportunities within immediate scope, for example streamlining validation documentation or adopting risk-based CSA practices.
  • Manage moderately complex delivery tasks and stakeholders across the delivery team, QA, and vendors.

What you'll need

  • Demonstrated experience managing small to medium-sized initiatives, projects, or workstreams within a product or larger context, ideally in a GxP-regulated environment (pharmaceutical, biotech, healthcare, or life sciences).
  • Hands-on experience with CSV and/or CSA lifecycles for implementation, upgrade, or migration of computerized systems, including coordinating validation deliverables with Quality Assurance.
  • Experience acting as a Scrum Master or Agile delivery lead for technical engineering squads, and applying project management governance (scope, budget, timeline) alongside Agile practices.
  • Experience overseeing vendors or implementation partners.
  • Experience independently analyzing less complex delivery problems, identifying root causes, and owning problem-solving plans.
  • Proven ability to build rapport with stakeholders, facilitate meetings, and manage stakeholder expectations within a defined area of responsibility.
  • Working knowledge of GxP regulations and related guidance, data integrity principles, and risk-based validation approaches, including CSA.
  • Understanding of business context for deliverables and application of business knowledge to problem-solving.
  • Applies standard delivery methodologies (Agile/Scrum, Waterfall, hybrid approaches, ITIL) with increasing proficiency, and can tailor them to regulatory requirements.
  • Familiarity with change control, deviation/CAPA management, and requirements traceability practices.
  • Capable of using delivery tools and techniques such as Jira, Confluence, and electronic quality or validation management systems.
  • Strong communication and collaboration skills, with the ability to build trust with product teams, QA, and peers.
  • Ability to balance rapid, iterative delivery with regulatory compliance and documentation rigor.

Nice to have

  • Relevant certifications (e.g., CSM/PSM).

Details

  • Location: Hyderabad.
  • Hybrid role.

Read the full description and apply on the company’s own careers page.

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IT Project Manager