Cerus
IT Portfolio & Project Manager
Concord, California
Sponsorship not specifiedDetected 7 days ago
ComplianceProject ManagementForecastingVendor ManagementCadenceFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationGxP
About the role
- Cerus is seeking a hands-on IT Portfolio & Project Manager to bring structure, visibility, and execution rigor to how IT work is requested, evaluated, prioritized, approved, tracked, and communicated.
Responsibilities
- Establish and manage a single front door for IT demand (intake forms, triage workflow, and centralized backlog).
- Develop and maintain simple definitions and thresholds to classify work (request vs enhancement vs project) and apply the appropriate level of governance.
- Partner with IT leadership and business stakeholders to implement a lightweight prioritization approach (scoring for strategic alignment, urgency, risk, effort).
- Facilitate regular portfolio review meetings to drive clear outcomes: approve, defer, reject, or request discovery and with decisions captured and communicated.
- Proactively manage expectations, align on scope and outcomes, and drive timely decisions and issue resolution.
- Directly manage and deliver IT projects (systems implementations, infrastructure initiatives, cybersecurity/compliance projects, process improvements) from intake through closeout.
- Lead project planning activities: scope definition, milestones, stakeholder alignment, communications, and implementation planning.
- Drive execution discipline: weekly status, issue/risk management, dependency tracking, change control, and escalation.
- Coordinate cross-functional delivery teams so SMEs can focus on technical execution while you manage planning, coordination, and stakeholder alignment.
- Coordinate and support Computer System Validation (CSV) activities, including validation planning, execution, and documentation, in alignment with company procedures.
Requirements
- Strong understanding of CSV, SDLC, and regulatory requirements for computerized systems.
- Familiarity with data integrity, cybersecurity, and FDA 21 CFR Part 11 compliance concepts.
Nice to have
- Ensure IT systems and project deliverables comply with applicable regulations and standards (FDA 21 CFR Part 11, ISO 13485, and GxP where applicable).
- Incorporate CSV, SDLC controls, and regulatory requirements into project plans, timelines, and deliverables (requirements, risk assessments, traceability, testing, approvals, and evidence packages).
- Produce executive-ready portfolio dashboards and summaries.
- Standardize project documentation and templates
- Track forecast vs actual costs for project work and highlight variances, risks, and decision points.
- Coordinate vendor milestones/deliverables and ensure invoicing aligns to outcomes.
- Identify bottlenecks, propose improvements, and evolve governance based on feedback and adoption.
- Coach and enable IT staff on consistent project practices (templates, reporting rhythm, role clarity).
This listing is sourced directly from Cerus's careers page and normalized into a canonical job model.