Project Manager II – AI-Enabled, GxP & Cross-Functional

Nova Biomedical; Waltham (MA); Hybrid; USD 91,000 - 121,000; Full time

Benefits offered by this job

Flexible Medical, Dental, Vision

Hybrid work arrangements

Tuition reimbursement

401k company match

Generous PTO & holidays

Job summary

Nova Biomedical is seeking a Project Manager II to lead cross-functional initiatives across regulatory and clinical markets. The role focuses on end-to-end delivery, including GxP validation, vendor management, and executive communication.

You will apply AI-enabled project management tools to drive decision-ready insights and achieve business outcomes. You will partner with senior leaders, manage budgets, and ensure inspection readiness while applying PMO standards in a hybrid Waltham, MA

Qualifications

• Bachelor's degree in a relevant field required; advanced degree preferred.
• Demonstrated track record of leading end-to-end projects with budget ownership and executive communication.
• Experience in a regulated industry with GxP concepts and CSV awareness.
• PMP certification or equivalent mastery (e.g., CSM, PgMP, PRINCE2) or in progress.
• Strong AI-enabled project management practice with examples.

Responsibilities

• Lead end-to-end project delivery from initiation through stabilization, including business case alignment and validation.
• Coordinate multiple workstreams across functional, technical, validation, change management, and training.
• Drive vendor selection, SOW management, and executive stakeholder relations.
• Manage GxP validation lifecycle (IQ/OQ/PQ, Validation Summary, inspection-ready docs).
• Prepare steering materials and decisions packages to support governance.
• Identify program risks and implement mitigation with PMO leadership.
• Own project budgeting, forecast, actuals, CapEx/OpEx tracking, and invoicing validation.
• Mentor PM I peers on PMO practices and AI tool adoption.
• Ensure compliance with FDA 21 CFR Part 11, ISO 13485, IEC 62304, EU MDR.

Skills

Project management

Vendor management

AI-enabled PM

Regulatory awareness

Stakeholder communication

Budget ownership

Education

Bachelor's degree in business, engineering, life sciences, IT, or related field

MBA / MS / MEng preferred

Tools

Jira

MS Project

Smartsheet

Asana

SAP

Salesforce

Job description

Nova Biomedical is seeking a Project Manager II to lead cross-functional initiatives across regulatory and clinical markets. The role focuses on end-to-end delivery, including GxP validation, vendor management, and executive communication.

You will apply AI-enabled project management tools to drive decision-ready insights and achieve business outcomes. You will partner with senior leaders, manage budgets, and ensure inspection readiness while applying PMO standards in a hybrid Waltham, MA