QMS Implementation Specialist / Project Manager

Industry Pharma/Biotech/Clinical Research
Remote Job

Job Description

This is a remote position.

QMS Implementation Specialist / Project Manager

Work Model: Primarily Remote with approximately monthly travel to Eastern PA

Industry: Life Sciences / Pharmaceutical / Biotechnology

Experience: 4–8 Years

Position Overview

Genovice is seeking a versatile QMS Implementation Specialist / Project Manager to support project-based Quality Management System (QMS) implementations for life sciences clients.

This role is ideal for someone with a broad skill set across QMS implementation, project management, system configuration, data migration, and/or computer system validation (CSV) . We are not looking for someone who specializes exclusively in one area. The ideal candidate will be comfortable wearing multiple hats throughout an implementation and supporting different phases of a project based on client needs.

This is an initial 6-month contract-to-hire opportunity , with the intention of transitioning the successful candidate into a full-time position based on performance and mutual fit.

Key Responsibilities

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

Qualifications

4–8 years of relevant experience within pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.
Hands‑on experience with QMS/eQMS implementation projects .
Experience in at least two or more of the following areas:

Project Management
QMS System Configuration
Data Migration
Computer System Validation (CSV)

Experience with one or more QMS platforms such as:

MasterControl
SOLABS
Similar electronic Quality Management Systems

Understanding of common quality processes such as deviations, CAPA, change control, document management, training, audits, and/or supplier quality.
Working knowledge of GxP requirements, data integrity principles, and 21 CFR Part 11.
Strong communication, organization, and client‑facing skills.
Ability to manage multiple priorities and adapt to different responsibilities throughout an implementation.

Preferred Qualifications

Experience supporting multiple QMS implementations or client‑facing implementation projects.

Experience with SuccessFactors or similar learning/training management platforms.

Experience working within a consulting or professional services environment.

Familiarity with system integrations and implementation lifecycle activities.

Experience supporting both technical and business stakeholders.

Location & Travel

Candidates located in Eastern Pennsylvania or Central New Jersey are strongly preferred. The role will primarily support projects remotely but requires the ability to travel approximately once per month to offices in the Bethlehem and/or Philadelphia, Pennsylvania area.

Engagement

This position will begin as an approximately 6-month contract engagement with a strong right-to-hire opportunity . The goal is to identify an individual who can grow into a long-term member of the team supporting ongoing QMS implementation projects.

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