Remote QMS Implementation Lead & PM - Contract-to-Hire

Zohorecruit; United States; Remote; USD 90,000 - 130,000; 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 involves cross-functional collaboration across quality, IT, validation, and client teams.

The position offers a 6-month contract-to-hire path with monthly travel to Eastern PA. You will handle configuration, data migration, CSV validation, and ensure compliance with GxP and 21 CFR Part 11 across projects.

Qualifications

• 4–8 years of relevant experience in regulated life sciences.
• Hands-on experience with QMS/eQMS implementation projects.
• Experience in two or more areas: Project Management, QMS System Configuration, Data Migration, CSV.
• Experience with MasterControl, SOLABS, or similar eQMS platforms.

Responsibilities

• Support end-to-end implementation of eQMS for life sciences organizations.
• Coordinate and manage QMS implementation activities, timelines, deliverables, risks, and stakeholder communication.
• Participate in system configuration and implementation activities based on business and quality requirements.
• Support data migration activities, including mapping, migration planning, verification, and reconciliation.
• Develop/execute validation documentation such as URS, risk assessments, test scripts, and validation summaries.
• Facilitate requirements gathering and translate business processes into system requirements.
• Support system testing, UAT, defect resolution, and readiness.
• Work with Quality, IT, Validation, stakeholders, vendors, and client teams.
• Assist with go-live, training, and post-implementation support.
• Ensure activities align with GxP, data integrity, and 21 CFR Part 11.

Skills

Project Management

QMS System Configuration

Data Migration

Computer System Validation (CSV)

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 involves cross-functional collaboration across quality, IT, validation, and client teams.

The position offers a 6-month contract-to-hire path with monthly travel to Eastern PA. You will handle configuration, data migration, CSV validation, and ensure compliance with GxP and 21 CFR Part 11 across projects.