QMS Implementation Specialist / Project Manager

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.