IT Project Manager (Contractor)

Position Summary:
The IT Project Manager will lead and deliver critical technology projects supporting GxP-compliant manufacturing, R&D, and clinical operations. This role will oversee new system implementations, system enhancements, and validation activities for existing systems, ensuring alignment with regulatory requirements and business priorities. The ideal candidate will be adept at managing cross-functional teams, driving timelines, and ensuring successful project outcomes in highly regulated life sciences environments.

Responsibilities:

• Project Leadership – Manage the full lifecycle of IT projects from planning through deployment, including requirements gathering, design, testing, go-live, and post-implementation support.
• Cross-Functional Collaboration – Lead and motivate cross-functional teams, fostering clear communication and accountability to ensure deliverables are met on time and within scope.
• Vendor & Stakeholder Management – Coordinate with internal stakeholders and external vendors; hold all parties accountable for timely completion of project tasks and milestones.
• Requirements Translation – Facilitate business requirements sessions, translate needs into actionable project plans, and manage change requests effectively.
• Risk & Issue Management – Proactively identify, assess, and mitigate project risks; escalate critical issues promptly with recommended solutions.
• Progress Tracking & Reporting – Maintain detailed project documentation, track progress against milestones, and provide weekly status reports to leadership.
• Validation Expertise – Support GxP validation and 21 CFR Part 11 compliance activities, ensuring documentation and testing meet regulatory and quality standards.
• Meeting & Event Coordination – Organize and facilitate key project events including system demos, document reviews, and testing sessions.
• Process Expertise – Develop and maintain deep knowledge of IT project management and GxP validation processes to guide teams effectively.
• Travel & Onsite Support – Be available during core business hours (9:00 am – 5:00 pm EST) and travel to company sites for critical project phases.

Qualifications:

• Bachelor’s degree in Information Technology, Computer Science, Engineering, or related discipline.
• 2–5 years of IT project management experience, including system implementation in regulated environments.
• 1–2 years in life sciences (cell therapy experience preferred).
• Experience in FDA-regulated industries strongly preferred.
• Proven track record leading GxP system implementations and validation projects (21 CFR Part 11).
• Strong command of Microsoft Office Suite; Smartsheet experience preferred.
• Exceptional organizational skills with the ability to manage multiple priorities in fast-paced environments.
• Strong facilitation and communication skills, capable of working effectively with technical and non-technical audiences.
• PMP certification a plus, but not required