Senior GxP IT Consultant

Stellent IT LLC Logo
Stellent IT LLC
Cambridge, MA, United States
  • IT

Title – Senior GxP IT Consultant

Location: Boston , MA (Onsite)

The Senior GxP IT Consultant will be responsible for working cross-functionally and collaboratively with outside vendors on GxP specific systems support.

Visa- OPEN
Duration: 1 Year Contract

JD:

Key Responsibilities:

  • Configure elluminate environments, modules, roles/permissions, and support compliant Release

Management activities.

  • Build and maintain ETL pipelines, metadata, mappings, and automated data quality/validation rules.
  • Configure elluminate study modules (Mapper, Data Central, CTOA, Sample Management, Protocol Deviations) and translate requirements into specifications.
  • Contribute in testing/validation (IQ/OQ/PQ, UAT) efforts, manage audit trails, and resolve issues with vendors and study teams.
  • Develop dashboards/analytics across elluminate modules and monitor system performance, integrations, and governance logs.
  • Support project governance, process standardization, template reuse, and continuous improvement across functions while ensuring GxP and regulatory compliance.
  • Support account management, routine user access reviews and release management activities for 25 Blueprint Medicines SaaS computerized systems that fall under GxP regulations.
  • Manage/Assist in creating Change Controls and System update-related documentation.
  • Interface effectively with system business owners, quality (QA), and associated partners.
  • Manage onsite/offsite GxP resources to ensure efficient communication and execution.
  • Schedule maintenance and manage incidents with outside vendor-network.
  • Collaborate with the QA organization to develop and execute scalable, risk-based, computerized systems validation (CSV) processes and procedures.
  • Arrange regular project governance meetings for assigned projects.
  • Actively participate in project meetings and walkthroughs.
  • Manage and oversee Account Management & Security processes for all BPMC regulated Systems.
  • Interface effectively with system business owners, quality and associated vendors.
  • Stay current with US and international regulations, industry standards, and emerging topics pertaining to GxP Computerized Systems, Computer Systems Validation and Data Integrity.
  • Prepare, review, and approve GxP Computerized Systems Validation life cycle and Change Control documents.

Qualifications:

  • 10 years of relevant experience supporting GxP projects

  • Hands-on familiarity with the elluminate platform and its modules (Mapper, Data Central, CTOA/Operational Analytics, Sample Management, Protocol Deviations, Clinical Analytics) or similar platforms

  • Knowledge of Veeva preferred

  • Strong verbal and written communication skills

  • Able to work independently

  • Bachelor’s or Master’s in Computer Science, Information Systems, Life Sciences, Bioinformatics, or similar.

  • Experience in clinical systems configuration, data engineering, clinical data platform delivery, or module implementations.

  • Proficiency in SQL, Python, API development/integration, ETL tools (Informatica/Talend/Fivetran), metadata management, and data lineage practices.

  • Strong knowledge of system validation frameworks and compliance (21 CFR Part 11, GxP, audit readiness).

  • Excellent ability to translate business requirements into technical configurations, collaborate with cross functional stakeholders, and deliver module-based solutions.

++Navnish kumar++

++Sr. IT Technical Recruiter++

++Stellent IT++ Phone++:++

Email: navnish

Gtalk: navnish++om++

Apply for job