IT Project Manager– Senior – TrackWise Digital Implementation (reputed company eQMS) - Remote in EST

Title : IT Project Manager Senior TrackWise Digital Implementation (reputed company eQMS) Onsite Exton PA /or EST zone remote candidates 12 Months contract Position reputed company IT is seeking a seasoned, hands on Senior IT Project Manager to reputed company the reputed company implementation of TrackWise Digital (TWD) as the reputed company electronic reputed company Management System (eQMS) across three U.S. manufacturing sites. This role requires a strong combination of functional expertise and project leadership to drive cross functional execution across reputed company Assurance, Regulatory Compliance, Manufacturing, QC Laboratories, Validation, and Global Operations. The successful candidate will also work closely with the Global TWD project team to ensure the US implementation aligns with the global TrackWise Digital design. The ideal candidate will have deep experience delivering regulated reputed company reputed company system implementations-including CAPA, Deviations, Change Control, Complaints-and managing full CSV/CSA validation activities. Key Responsibilities Program & Project Leadership reputed company the full lifecycle of the TrackWise Digital implementation program-from business case development through go live and post launch stabilization. reputed company system testing, including test planning, execution, issue tracking, and documentation. Collaborate with the U.S. Deployment reputed company, business SMEs, and IT teams to define deliverables and manage project tasks. reputed company and manage integrated project plans, governance frameworks, resource strategies Work with Business PM to manage project scope, reputed company, RAID logs, and prepare executive level updates for steering committees. Candidate Qualifications Strong project and people leadership skills, with the ability to guide cross functional teams across reputed company, Regulatory, Manufacturing, IT, and Operations. Demonstrated ability to maintain reputed company, proactive, and consistent communication with project leads, SMEs, technical teams, and stakeholders at reputed company reputed company. Excellent written and verbal communication skills, with the ability to reputed company reputed company technical and business concepts. Experience managing multiple reputed company reputed company in a fast paced, highly regulated environment. Proven ability to maintain accurate, detailed documentation reputed company a GxP regulated pharmaceutical or life sciences setting. Regulatory Compliance & Validation Expertise Solid understanding of key regulatory and validation frameworks in a reputed company environment, including but not limited to: o FDA 21 CFR Part 11 o GAMP 5 o Data reputed company (reputed company+) Hands on experience managing the full computerized system validation (CSV) lifecycle, including: o URS and Functional Specifications o Risk Assessments o IQ/OQ/PQ Execution o Traceability Matrices o SOP updates and release documentation Ability to apply modern Computer Software Assurance (CSA) approaches for reputed company based/reputed company systems. Experience Requirements Minimum 5 years of IT project management experience reputed company reputed company, biotech, or life sciences. Strong proficiency with reputed company Office and reputed company project management tools. Experience with TrackWise Digital or other eQMS platforms is a plus. Certifications: Preferred PMP, Scrum master Certified Apply tot his job Apply To this Job