Spec 2, Project/Program Mgmt

LanceSoft•Milpitas, CA

About The Position

The Senior Project/Program Manager will support a major global regulatory registration and product transition program, along with other strategic integration initiatives within the Biosciences organization. Functional subject matter experts own and perform the underlying regulatory, quality, technical, labeling, operational, commercial, and IT work. The manager integrates these activities into an executable plan, tracks progress, manages dependencies and risks, and drives timely decisions and accountability across the team. The successful candidate is a proactive, analytical project leader who can independently structure complex work, maintain reliable program data and reporting, and communicate effectively with project teams and senior stakeholders. The position is based in Milpitas, California, with remote candidates potentially considered based on experience and qualifications. Pacific time hours are preferred. The contract duration is October 30, 2026 through October 29, 2027.

Requirements

Bachelor’s degree in business, science, engineering, operations, information systems, or a related discipline.
Ten or more years of progressive project or program management experience.
Experience managing complex, cross-functional projects or workstreams in a regulated life sciences environment.
Demonstrated experience managing integrated plans, milestones, dependencies, risks, issues, decisions, and accountability across multiple functions.
Working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submission processes.
Strong analytical and data management capabilities, including experience developing project databases, dashboards, and data-driven reporting solutions.
Advanced proficiency with Microsoft Excel and strong proficiency with Power BI or a comparable data visualization tool.
Proficiency with PowerPoint, Teams, SharePoint, and project planning or collaboration tools.
Strong written, verbal, facilitation, presentation, and stakeholder management skills.
Ability to influence and drive accountability without direct authority.
Ability to independently structure ambiguous work and drive it to completion.
Ability to balance detailed workstream execution with broader program priorities and changing requirements.
Ability to translate project data into clear insights, decisions, and actions.
Sound judgment in issue resolution, escalation, and prioritization.
Ability to manage multiple priorities effectively in a fast-moving environment.
High standards for detail, data quality, and reporting accuracy.
Integrated project planning skills, including building and maintaining plans covering scope, deliverables, milestones, dependencies, owners, resources, and target dates.
Working knowledge of global product registrations, re-registrations, submission readiness, and regulatory documentation processes.
Familiarity with dossier development, document readiness, review cycles, submission inputs, and approval dependencies.
Working knowledge of quality management systems, design controls, compliance requirements, and change control.
Experience coordinating labeling changes, artwork development, review and approval workflows, and implementation readiness.
Proficiency managing risks, actions, issues, decisions, assumptions, and cross-functional dependencies.
Ability to identify sequencing constraints, schedule conflicts, downstream impacts, and critical-path risks.
Experience designing and maintaining structured project databases, trackers, and reliable reporting processes.
Strong Excel capability with formulas, pivot tables, lookups, data validation, reconciliation, and analysis.
Ability to develop and maintain dashboards communicating milestones, overdue deliverables, risks, trends, and leadership actions.
Proficiency with Microsoft PowerPoint, Teams, SharePoint, and project-planning platforms such as Smartsheet or Microsoft Project.

Nice To Haves

Direct experience supporting global medical device or in vitro diagnostic product registrations or re-registrations.
Experience supporting regulatory submissions, technical documentation readiness, labeling transitions, or compliance remediation programs.
Experience with business integration, transformation, M&A, or other enterprise-level initiatives.
Experience working with global teams across multiple functions, regions, or business units.
PMP, PgMP, or equivalent project management certification.
Experience coordinating technical dossier development, remediation, review, and submission readiness.
Familiarity with labeling and artwork management systems, including review and approval workflows.
Experience supporting quality management system, design control, change control, or compliance remediation initiatives.
Experience managing product transitions with dependencies across regulatory, quality, operations, supply chain, commercial, and IT teams.
Working knowledge of Smartsheet, Microsoft Project, Microsoft Planner, or comparable project-planning tools.
Experience with SharePoint-based data structures, document libraries, and program reporting.
Experience automating reporting or workflows using Power Query, Power Automate, or comparable tools.
Experience supporting M&A integration, business transformation, or enterprise-level programs.
Experience working with global teams across multiple regions, business units, and time zones.

Responsibilities

Lead assigned projects and workstreams, translating program objectives into clear scope, deliverables, milestones, owners, dependencies, and target dates.
Build and maintain integrated project plans aligning regulatory, technical documentation, labeling, quality, R&D, operations, supply chain, commercial, and IT activities.
Coordinate across functional leaders and subject matter experts, monitor commitments, resolve planning gaps, and drive deliverable completion in a matrix environment.
Identify and manage risks, issues, actions, decisions, assumptions, schedule conflicts, and resource constraints.
Assess downstream impacts of changes and delays, establish mitigation plans with accountable owners, and escalate material items through appropriate governance channels.
Facilitate cross-functional planning sessions, working meetings, risk reviews, and decision discussions.
Ensure meeting outcomes, approved decisions, and changes are reflected in project plans, reporting, and communications.
Apply working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submissions to support planning, sequencing, documentation readiness, and submission readiness.
Prepare concise status updates for project teams and leadership, highlighting progress, upcoming milestones, overdue actions, risks, dependencies, decisions, and required support.
Design and maintain practical project databases, trackers, dashboards, and reporting processes.
Consolidate information from multiple workstreams and analyze project data to identify trends, emerging risks, and areas requiring leadership attention.
Improve the quality, consistency, and efficiency of program reporting, including simplifying or automating recurring data collection where appropriate.