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 escalate 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.
Work Location: Hybrid work schedule in Waltham, MA (M-Th Onsite)Targeted Salary Range: $91,000-121,000/yrNova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.
