QMS Implementation Specialist / Project Manager

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.