QMS Implementation Specialist / Project Manager

Jobgether SRL; Town of Bethlehem (NY); Remote; USD 110,000 - 140,000; Part time

Benefits offered by this job

Remote work

Contract-to-hire

Travel to PA

Career growth

Job summary

Jobgether SRL is seeking a QMS Implementation Specialist / Project Manager for a remote contract-to-hire role in the United States. You will lead end-to-end eQMS deployment for life sciences clients, coordinate project timelines and validation activities, and collaborate with Quality, IT, and client teams.

Travel to Eastern Pennsylvania is expected about once per month. The ideal candidate has 4–8 years in regulated life sciences, hands-on QMS experience, and familiarity with platforms like

Qualifications

• 4–8 years in regulated life sciences (pharma/biotech/medical devices).
• Hands-on support for QMS/eQMS implementations.
• Experience in two areas: PM, QMS configuration, data migration, or CSV validation.
• Knowledge of GxP, 21 CFR Part 11, deviations, CAPA, change control, document management.
• Familiarity with LMS platforms like SuccessFactors is a plus.

Responsibilities

• Lead end-to-end eQMS implementations for life sciences clients.
• Coordinate timelines, deliverables, risks, and stakeholder communications.
• Configure systems and perform data migration planning and validation.
• Develop URS, risk assessments, test scripts, and validation summaries.
• Support testing, UAT, defect resolution, and go-live activities.
• Collaborate with Quality, IT, Validation, vendors, and client teams.
• Provide training support and post-implementation support.
• Ensure activities align with GxP and data integrity standards.

Skills

QMS implementation

Project management

Data migration

CSV validation

Quality systems

Regulatory knowledge

Client-facing

Tools

Veeva Quality

MasterControl

ZenQMS

SOLABS

eQMS platforms

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a QMS Implementation Specialist / Project Manager based in United States.

This role supports end-to-end Quality Management System (QMS) implementations for clients across the life sciences industry. You will combine project management, system implementation, configuration, data migration, and validation expertise to help deliver successful eQMS projects. The position offers variety, with opportunities to contribute across different phases of an implementation based on project and client needs. You will work closely with Quality, IT, Validation, business stakeholders, vendors, and client teams to translate requirements into effective solutions. Your work will help ensure systems meet regulatory, quality, and data integrity expectations. This is a remote contract-to-hire opportunity with potential for long-term growth and approximately monthly travel to Eastern Pennsylvania.

Accountabilities:

• Support end-to-end implementation of electronic Quality Management Systems (eQMS) for life sciences organizations.
• Coordinate QMS implementation activities, project timelines, deliverables, risks, and stakeholder communications.
• 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 execute validation documentation, including User Requirements Specifications (URS), risk assessments, test scripts, traceability matrices, and validation summaries.
• Facilitate requirements gathering and translate business processes into system requirements and workflows.
• Support system testing, user acceptance testing (UAT), defect resolution, and implementation readiness.
• Collaborate with Quality, IT, Validation, business stakeholders, vendors, and client project teams.
• Assist with system go-live, deployment, training, and post-implementation support.
• Ensure implementation activities align with applicable GxP requirements, data integrity principles, and 21 CFR Part 11.

Requirements:

• 4--8 years of relevant experience in pharmaceutical, biotechnology, medical device, or another regulated life sciences environment.
• Hands-on experience supporting QMS or eQMS implementation projects.
• Experience in at least two of the following areas: project management, QMS system configuration, data migration, or computer system validation (CSV).
• Experience with QMS platforms such as Veeva Quality, MasterControl, ZenQMS, SOLABS, or similar electronic Quality Management Systems.
• Understanding of quality processes including 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, organizational, and client-facing skills, with the ability to manage multiple priorities.
• Ability to adapt to different responsibilities and contribute across multiple phases of an implementation.
• Experience supporting multiple QMS implementations or client-facing implementation projects is preferred.
• Experience with SuccessFactors or similar learning and training management platforms is a plus.
• Consulting or professional services experience, familiarity with system integrations, and experience working with both technical and business stakeholders are preferred.
• Candidates based in Eastern Pennsylvania or Central New Jersey are strongly preferred, with the ability to travel approximately once per month to the Bethlehem and/or Philadelphia, Pennsylvania area.

Benefits:

• Initial 6-month contract-to-hire engagement with a strong opportunity to transition into a full-time position.
• Primarily remote work arrangement.
• Approximately monthly travel to Eastern Pennsylvania as required by client projects.
• Opportunity to work on QMS implementation projects within the pharmaceutical, biotechnology, and broader life sciences sectors.
• Potential for long-term career growth supporting ongoing QMS implementation projects.
• Full-time opportunity following successful completion of the initial contract period and mutual fit.

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.