QMS Implementation Specialist / Project Manager
About this role
This is a remote position.
QMS Implementation Specialist / Project ManagerContract-to-Hire | 6 Months Initial ContractLocation:Eastern Pennsylvania / Central New Jersey preferredWork Model:Primarily Remote with approximately monthly travel to Eastern PAIndustry:Life Sciences / Pharmaceutical / BiotechnologyExperience:4–8 YearsPosition Overview
Genovice is seeking a versatileQMS Implementation Specialist / Project Managerto support project-based Quality Management System (QMS) implementations for life sciences clients.
This role is ideal for someone with a broad skill set acrossQMS 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 initial6-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.
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 withQMS/eQMS implementation projects.
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Experience in at leasttwo or moreof the following areas:
Project Management
QMS System Configuration
Data Migration
Computer System Validation (CSV)
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Experience with one or more QMS platforms such as:
Veeva Quality
MasterControl
ZenQMS
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.
4–8 years of relevant experience within pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.
Hands-on experience withQMS/eQMS implementation projects.
Experience in at leasttwo or moreof the following areas:
Project Management
QMS System Configuration
Data Migration
Computer System Validation (CSV)
Experience with one or more QMS platforms such as:
Veeva Quality
MasterControl
ZenQMS
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 withSuccessFactorsor 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.
Experience supporting multiple QMS implementations or client-facing implementation projects.
Experience withSuccessFactorsor 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 inEastern Pennsylvania or Central New Jerseyare strongly preferred. The role will primarily support projects remotely but requires the ability to travel approximatelyonce per monthto offices in the Bethlehem and/or Philadelphia, Pennsylvania area.
Engagement
This position will begin as an approximately6-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.
Originally posted on Himalayas
