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.