Project Manager, Pharma IT Infrastructure and Operations - Fall River, Massachusetts

Contract Project Manager, Pharma IT Infrastructure and Operations - Hybrid, Hampton, New Jersey Job Summary

The Contract Project Manager, Pharma IT Infrastructure and Operations is a pivotal role responsible for executing projects across the entire lifecycle of commercial, clinical, regulatory, and R&D IT initiatives, from supporting market launch to post-launch support. This position reports directly to the PMO Lead and ensures projects are delivered on time, within budget, and meet high-quality standards while aligning with strategic business objectives.

Project Management & Execution

• Manage end-to-end project lifecycle for IT infrastructure, operations, and R&D technology initiatives.
• Develop and maintain detailed project plans, including scope, schedule, budget, and risk management.
• Lead cross‑functional project teams across commercial, clinical, regulatory, and R&D domains.
• Track project progress and provide regular status updates to stakeholders.
• Conduct project status meetings and manage change control processes.
• Spearhead process streamlining, training, audits, and KPI/metrics tracking.
• Analyze and communicate risk and compliance adherence principles.
• Implement corrective action plans and conduct root cause analysis.
• Support enterprise‑wide IT systems, networks, and cloud solutions.
• Optimize IT service management processes including continuous improvement and change management.

GxP & R&D Support (30% Time Allocation)

• Dedicate 30% of time to GxP project work in GLP & GMP environments.
• Collaborate with the R&D ITBP to align IT projects with R&D needs.
• Manage upgrade & implementation projects for R&D‑specific IT projects (e.g., ELN, scientific computing).
• Ensure compliance with GxP, FDA 21 CFR Part 11.
• Support vendor qualifications and audits for GxP systems.
• Maintain documentation and SOPs for audit readiness.
• Support Phase II of PMO development, including:
  • Expansion of PMO scope to R&D.
  • Implementation of Stage Gate governance (Q2 2026).
  • Integration of R&D projects into Smartsheet.
  • Support for BRM framework formalization.
• Contribute to project intake, metrics dashboards, and governance workflows.
• Provide feedback to support PMO maturity and continuous improvement.
• Demonstrate adaptability and comfort with ambiguity in evolving environments.
• Collaborate with the Sr. Executive Director of Infrastructure and Operations and security teams.
• Foster a culture of continuous improvement and innovation.
• Build strong relationships across IT, R&D, QA, and compliance teams.

Education & Experience

• Bachelor’s degree (or equivalent experience) in Computer Science, Information Technology, or related field.
• 7+ years of IT experience with 3–5 years in project management roles.
• 5+ years of experience in commercial pharma, biotech, or clinical research.
• 2-5 years of experience in business analysis is preferred.
• Experience in regulated environments (Pharma, Biotech, Clinical, Medical Device).

Technical & Regulatory Expertise

• Strong understanding of GxP, FDA 21 CFR Part 11, HIPAA, GDPR, ISO 27001.
• Experience with GLP environments and R&D IT systems (e.g., LIMS, ELN).
• Experience with data warehousing, reporting, and analytics.
• Proven success in implementing enterprise IT solutions across domains.
• Experience with global, multi‑site IT operations.

Project Management Skills

• Proficiency in project management tools (e.g., Smartsheet, MS Project, JIRA).
• Strong documentation, communication, and stakeholder engagement skills.
• Ability to manage multiple concurrent projects and priorities.
• Experience with vendor management and contract negotiation.
• Ability to collaborate with ITBPs and cross‑functional teams.

Core Competencies

• Comfort with ambiguity and evolving processes.
• Strategic thinking and alignment with business/regulatory needs.
• Strong problem‑solving and analytical skills.
• Effective collaboration across diverse teams.

• PMP Certification
• BRM Certification Smartsheet Certification
• Experience with JIRA

Monday to Friday, 8:00 AM to 5:00 PM. Flexibility required for time zones and occasional overtime. On‑camera presence expected for remote meetings with appropriate business attire and…