Senior/Lead Technical Project Manager – Global LIMS

Jobtailor; Bengaluru; On-site; INR 3,000,000 - 5,400,000; Full time

Job summary

Jobtailor in Bengaluru, India is seeking an experienced Technical Project Manager to lead LIMS implementation and upgrade programs in a regulated Life Sciences environment. You will collaborate with Lab Operations, Quality, IT and vendors, drive CSV strategy, review validation artifacts, and ensure data integrity while adopting automation.

12+ years in software and 6+ years in TPM roles with LabVantage LIMS are preferred.

Qualifications

• 12+ years of software development experience.
• Minimum 6+ years as a Technical Project Manager handling LabVantage LIMS (v8.5+).
• Extensive experience in CSV within a regulated Life Sciences environment.
• Strong knowledge of GxP, GAMP 5 and 21 CFR Part 11.
• Experience with LIMS development and system integrations.

Responsibilities

• Own end-to-end delivery of LIMS implementation and upgrade programs.
• Create and maintain execution plans aligned with timelines and budgets.
• Act as the voice of Quality across cross-functional teams and drive CSV standards.
• Review and approve technical documentation, risk assessments, and validation protocols.
• Lead requirement analysis and design discussions with business users.
• Support audits and regulatory inspections with validation data.

Skills

LIMS (LabVantage)

CSV

GxP/GAMP 5/21 CFR Part 11

RESTful APIs

SOAP services

MuleSoft

Stakeholder management

English communication

Regulatory compliance

Project management

Education

Bachelor's degree in Computer Science, Information Technology or related field

Tools

MuleSoft

REST APIs

SOAP

Job description

Responsibilities

• Owning end-to-end delivery of LIMS implementation and upgrade programs, ensuring alignment with laboratory operations, business goals and regulatory requirements
• Creating and maintaining comprehensive execution plans aligned with project timelines, budgets and our Quality Management System (QMS)
• Acting as the voice of Quality in cross-functional teams, driving CSV strategy and standards across all project phases
• Reviewing and approving technical documentation, risk assessments, CSV protocols, test scripts and deviations in line with Novo Nordisk quality standards
• Leading requirement analysis, design and development discussions with Line of Business and end users to deliver feasible, compliant solutions
• Supporting the globalLIMS AM team on critical incidents, root cause analysis and deployment activities for planned and unplanned releases
• Adopting AI and automation technologies to enable faster releases, while upholding data integrity processes by proactively identifying and escalating risks
• Supporting internal audits and regulatory inspections with summarised validation data and coordinated regulatory responses

Requirements

• A Bachelor's degree in Computer Science, Information Technology or a related field
• 12+ years of professional experience in software development, including a minimum of 6+ years as a Technical Project Manager working with LabVantage LIMS (v8.5 or higher) in a regulated Life Sciences environment
• Significant experience in the pharmaceutical industry with a focus on Computer Systems Validation (CSV); deep experience with LIMS or MES implementation is highly preferred
• Strong knowledge of GxP, GAMP 5 and 21 CFR Part 11, with familiarity in automation test management tools and data integrity, change control and validation expectations
• Extensive experience in LIMS development and system integrations using RESTful APIs, SOAP services and middleware platforms (e.g., MuleSoft) for scalable, secure and compliant integrations with enterprise applications
• Proven stakeholder management skills, working across laboratory users, Quality, IT, vendors and integration partners – with the ability to translate business needs into effective technical solutions
• Excellent verbal and written communication skills in English, coupled with strong interpersonal, decision-making and coordination abilities across diverse cultures and time zones.

Core Competencies

Demonstrates expertise in LIMS implementation and upgrades, ensuring compliance with regulatory standards and alignment with laboratory operations. Proficient in stakeholder management and communication, driving effective project delivery in a regulated Life Sciences environment.