Project Manager II

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: One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

Job Summary

Nova Biomedical is a fast-growing, global leader in scientific and analytical solutions serving the bioprocessing and clinical markets. We are in the midst of an exciting transformation, bringing together innovation, quality, and customer focus under a unified New Nova identity, and we’re looking for a Project Manager II to help support cross-functional initiatives. Reporting to the VP, Corporate Projects and Communication, and working closely with senior leaders across the business, this role owns full projects end-to-end, including GxP-validated systems and cross-functional initiatives. The Project Manager II operates independently within PMO standards, defines scope and schedule, and is accountable for delivering business outcomes — not just on-time execution. This role serves as a peer-level partner to business owners, technical leads, and consulting partners. A strong AI-enabled project management practice is required, including the ability to use AI for executive-grade analysis, dependency mapping, and decision-ready synthesis.

Responsibilities

• Own end-to-end project delivery by leading projects from initiation through hypercare, including charter development, business case alignment, vendor selection, build, test, validation, deployment, and stabilization.
• Coordinate multiple workstreams across functional, technical, validation, change management, and training areas within a single project. May provide direction to one or more Project Manager I peers.
• Drive vendor and SOW execution by leading vendor selection processes, supporting SOW negotiations with Legal and Procurement, and managing vendor delivery against contractual commitments. Maintain executive-level vendor relationships.
• Manage the GxP validation lifecycle for assigned systems, including User Requirements, Functional Requirements, IQ/OQ/PQ protocols, Validation Summary Reports, and inspection-ready documentation. Coordinate closely with Quality and Validation leads.
• Support cross-functional decision-making by preparing steering committee materials, running design alignment workshops, and structuring decision packages with clear options, recommendations, and trade-offs. Maintain decision logs that can support audit and inspection needs.
• Identify and manage program-level risks beyond the immediate project scope. Build mitigation plans with named owners and trigger criteria, and elevate to PMO leadership with proposed solutions.
• Own project financial management, including budget, forecast, and actuals. Manage CapEx and OpEx categorization, track consulting hours, validate invoices against SOW deliverables, and report variance to PMO leadership and Finance.
• Mentor and support Project Manager I peers by providing informal coaching on PMO methodology, AI tool adoption, and stakeholder management. Contribute to the PMO knowledge base and template library.
• Maintain working fluency in FDA 21 CFR Part 11, ISO 13485, IEC 62304, and EU MDR as they apply to assigned projects. Partner with Regulatory Affairs and Quality on inspection readiness.

Experience Requirements

• Bachelor’s degree in business, engineering, life sciences, IT, or a related field required; equivalent experience will be considered. Advanced degree such as MBA, MS, or MEng is strongly preferred.
• Demonstrated track record of leading projects end-to-end in a professional setting, including budget ownership, vendor management, and executive communication.
• Working fluency with project management methodologies, including Waterfall, Agile, and hybrid approaches, with the ability to apply the right methodology based on business context.
• Experience in a regulated industry required; medical device experience strongly preferred. Biotech, pharma, clinical, lab, or IVD experience is also acceptable.
• Working knowledge of GxP concepts, including CSV, Computer System Validation, change control, deviation management, and CAPA processes.
• PMP certification, certification in progress, or equivalent demonstrated mastery such as CSM, PgMP, PRINCE2, or comparable experience.
• Strong AI-enabled project management practice, with the ability to walk through specific examples of how AI has improved project delivery, including tool choices, prompt design, validation steps, and lessons learned.
• Excellent written and verbal communication skills, including direct interaction with executive stakeholders at the Director level and above.
• Familiarity with enterprise platforms such as SAP, Salesforce, or equivalent systems, particularly in the context of implementation programs.
• Preferred experience includes direct medical device industry experience with FDA / EU MDR submission familiarity, fluency with Smartsheet, Jira, MS Project, or Asana, and Six Sigma Green Belt, Lean, or business process improvement certifications.

Physical Requirements And Working Conditions

• Ability to work at a computer for extended periods.
• Ability to lift and carry up to [25–50] pounds as required.
• Ability to communicate effectively via phone, video, and written communication.
• Ability to occasionally move about the office to access meetings or resources.

Why Work for Nova Biomedical

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

Work Location

Hybrid work schedule in Waltham, MA (M‑Th Onsite)

Targeted Salary Range

$91,000‑121,000/yr

About The Company

At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science‑driven solutions are trusted in over 100 countries to speed drug development and enhance patient care. Our integration brings together more than 70 years of scientific excellence with Nova’s cutting‑edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA‑registered, ISO‑certified manufacturing, more than 125 FDA approvals, and industry‑trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences. With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity. Working at Nova Biomedical means joining a mission‑driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you’ll be part of a team that values innovation, invests in your growth, and is committed to making a real‑world impact on global health.

EEO Statement

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.