Position: EtQ Project Manager & Validation Lead
Location - Rahway, NJ (Remote position but require a few days on-site in the first week)
12 Months
Role Summary
Seeking an experienced EtQ professional to manage EtQ implementations while leading project management, CSV/validation activities, and SDLC documentation in a regulated environment.
Key Responsibilities
Lead EtQ implementation and enhancement projects end-to-end as Project Manager
Plan, track, and manage project scope, timeline, risks, and stakeholders
Act as Validation Lead ensuring compliance with GxP, FDA 21 CFR Part 11, and CSV standards
Develop, review, and maintain SDLC documentation including URS, FRS, DDS, IQ/OQ/PQ, RTM, SOPs
Coordinate with business, QA, IT, and vendors for requirements and delivery
Oversee change control, risk assessments, and release management
Ensure system readiness for audits and inspections
Support system upgrades, patches, and continuous improvements
Required Skills & Experience
Strong hands-on experience with EtQ (Reliance/QMS modules)
Proven experience as Project Manager in regulated IT/QMS projects
Solid knowledge of Computer System Validation (CSV)
Expertise in SDLC lifecycle and documentation standards
Familiarity with quality processes (CAPA, Deviations, Change Management, Audits)
Excellent communication, stakeholder management, and documentation skills
Preferred Qualifications
Experience in pharma, life sciences, or medical devices
PMP or similar project management certification
Experience supporting regulatory audits