Title : IT Project Manager Senior TrackWise Digital Implementation (Pharma eQMS) Onsite Exton PA /or EST zone remote candidates
12 Months contract Position Summary
IT is seeking a seasoned, hands on Senior IT Project Manager to lead the enterprise implementation of TrackWise Digital (TWD) as the next generation electronic Quality 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 Quality 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 SaaS quality system implementations-including CAPA, Deviations, Change Control, Complaints-and managing full CSV/CSA validation activities. Key Responsibilities
Program & Project Leadership
Lead the full lifecycle of the TrackWise Digital implementation program-from business case development through go live and post launch stabilization.
Oversee system testing, including test planning, execution, issue tracking, and documentation.
Collaborate with the U.S. Deployment Lead, business SMEs, and IT teams to define deliverables and manage project tasks.
Develop and manage integrated project plans, governance frameworks, resource strategies
Work with Business PM to manage project scope, timeline, 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 Quality, Regulatory, Manufacturing, IT, and Operations.
Demonstrated ability to maintain open, proactive, and consistent communication with project leads, SMEs, technical teams, and stakeholders at all levels.
Excellent written and verbal communication skills, with the ability to articulate complex technical and business concepts.
Experience managing multiple concurrent projects in a fast paced, highly regulated environment.
Proven ability to maintain accurate, detailed documentation within a GxP regulated pharmaceutical or life sciences setting.
Regulatory Compliance & Validation Expertise
Solid understanding of key regulatory and validation frameworks in a pharma environment, including but not limited to:
o FDA 21 CFR Part 11
o GAMP 5
o Data Integrity (ALCOA+)
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 cloud based/SaaS systems. Experience Requirements
Minimum 5 years of IT project management experience within pharma, biotech, or life sciences.
Strong proficiency with Microsoft Office and collaborative project management tools.
Experience with TrackWise Digital or other eQMS platforms is a plus.
Certifications:
Preferred PMP, Scrum master Certified