IT Portfolio & Project Manager

Cerus•Concord, CA

37d•Hybrid

About The Position

Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world. This is a hybrid role requiring two days per week in our Concord, CA office. Position Summary 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. This role will serve as the initial “PMO-of-one,” building foundational project intake and governance practices while directly managing and delivering IT projects end-to-end. The successful candidate will reduce reliance on technical SMEs as ad-hoc project managers, improve strategic alignment and decision-making, and increase delivery predictability - while ensuring IT projects and computerized systems meet applicable regulatory and validation requirements.

Requirements

Bachelor’s degree in Information Systems, Business, Project Management, or equivalent experience.
5+ years of IT project management experience in a regulated environment (medical devices, pharma, biotech, healthcare).
Strong understanding of CSV, SDLC, and regulatory requirements for computerized systems.
Familiarity with data integrity, cybersecurity, and FDA 21 CFR Part 11 compliance concepts.
Demonstrated experience establishing or improving project processes (intake, governance, reporting) in an environment with limited prior structure.
Strong ability to communicate project status and issues clearly to both technical and non-technical audiences.

Nice To Haves

Hands-on experience supporting or leading Computer System Validation (CSV) for enterprise applications and/or infrastructure supporting regulated processes.
Familiarity with FDA, ISO (including ISO 13485), and GxP regulations/expectations.
Experience coordinating vendor-led projects and managing SOW-based delivery.
Project management certification (PMP, CAPM, PMI-ACP, Scrum Master) is a plus but not required.

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.
Serve as the primary point of contact between IT, business stakeholders, and vendors for assigned projects and portfolio initiatives.
Translate business needs into actionable requirements, project charters, and delivery plans in partnership with IT SMEs and functional owners.
Facilitate project status meetings and communicate progress, risks, dependencies, and decisions to stakeholders and leadership.
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.
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).
Collaborate with stakeholders and system owners to address data integrity, cybersecurity considerations, and validation expectations for computerized systems.
Build and run an IT project governance cadence (weekly/biweekly) that provides visibility into status, risks, dependencies, and decisions needed.
Maintain an auditable decision log and ensure stakeholders understand tradeoffs, scope impacts, and sequencing.
Produce executive-ready portfolio dashboards and summaries.
Standardize project documentation and templates
Implement a practical approach to project financial tracking starting with vendor/SOW costs (quotes, POs, invoices) plus rough internal effort estimates to support forecasting and tradeoffs.
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).
Contribute to an IT roadmap view by linking demand and projects to business priorities and compliance/security needs.