QMS Implementation Specialist / Project Manager

📋 Description

• Support end-to-end implementation of electronic Quality Management Systems (eQMS) for life sciences
• Coordinate QMS implementation activities, project timelines, deliverables, risks, and stakeholder
• Participate in system configuration and implementation activities based on business and quality
• Support data migration activities, including data mapping, migration planning, verification, and
• Develop and execute validation documentation, including User Requirements Specifications (URS)
• Facilitate requirements gathering and translate business processes into system requirements and

🎯 Requirements

• 4–8 years of relevant experience in pharmaceutical, biotechnology, medical device, or another
• Hands-on experience supporting QMS or eQMS implementation projects.
• Experience in at least two of the following areas: project management, QMS system configuration
• Experience with QMS platforms such as Veeva Quality, MasterControl, ZenQMS, SOLABS, or similar
• Understanding of quality processes including deviations, CAPA, change control, document management
• Working knowledge of GxP requirements, data integrity principles, and 21 CFR Part 11.

🎁 Benefits

• Initial 6-month contract-to-hire engagement with a strong opportunity to transition into a
• 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
• 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.