Remote QMS Implementation & Project Manager

Zohorecruit; Pennsylvania; Remote; USD 90,000 - 150,000; Full time

Job summary

Genovice is seeking a versatile QMS Implementation Specialist / Project Manager to support project-based QMS implementations for life sciences clients. This remote role requires coordinating activities across QMS configuration, data migration, and CSV validation, with occasional travel to Eastern PA.

Ideal candidates will wear multiple hats across implementation phases, manage timelines and risks, and collaborate with Quality, IT, Validation, and client teams.

Qualifications

• 4–8 years of experience in regulated life sciences (pharma/biotech/medical devices).
• Hands-on QMS/eQMS implementation experience.
• Experience in two or more areas: Project Management, QMS Configuration, Data Migration, CSV.
• Understanding of 21 CFR Part 11 and GxP requirements.

Responsibilities

• Lead end-to-end eQMS implementations for life sciences clients.
• Manage project timelines, deliverables, risks, and stakeholders.
• Assist in system configuration and implementation activities.
• Support data mapping, migration planning, verification, and reconciliation.
• Create URS, risk assessments, test scripts, and validation summaries.
• Translate business processes into system requirements and workflows.
• Support testing, UAT, defect resolution, and go-live readiness.
• Coordinate with Quality, IT, Validation, vendors, and client teams.
• Provide post-implementation support and training.
• Ensure compliance with GxP and 21 CFR Part 11.

Skills

Project Management

QMS Configuration

Data Migration

CSV Validation

Tools

MasterControl

SOLABS

Job description

Genovice is seeking a versatile QMS Implementation Specialist / Project Manager to support project-based QMS implementations for life sciences clients. This remote role requires coordinating activities across QMS configuration, data migration, and CSV validation, with occasional travel to Eastern PA.

Ideal candidates will wear multiple hats across implementation phases, manage timelines and risks, and collaborate with Quality, IT, Validation, and client teams.