Project Manager

Soho Square Solutions; Milpitas (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Soho Square Solutions in Milpitas, CA seeks an experienced Senior Project/Program Manager to support a major global regulatory registration and product transition program within the Biosciences organization.

The role requires structuring complex work, building integrated plans, tracking progress, managing dependencies and risks, and communicating with senior stakeholders to drive timely decisions and accountability across the team.

Qualifications

• 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 in a regulated life sciences environment.
• Experience managing integrated plans, milestones, risks, issues, decisions, and accountability.
• Knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submission processes.
• Strong data management and reporting capabilities; SQL/BI skills a plus.
• Advanced Excel and Power BI proficiency; PowerPoint/Teams/SharePoint fluency.

Responsibilities

• Lead assigned projects and workstreams, translating objectives into scope, milestones and owners.
• Build integrated plans aligning regulatory, labeling, quality, R&D, ops, supply chain, commercial, and IT activities.
• Coordinate across functional leaders, monitor commitments, and drive timely deliverables in a matrix environment.
• Identify and manage risks, issues, actions, decisions, and resource constraints.
• Assess downstream impact of changes and escalate material items through governance channels.
• Facilitate planning sessions, risk reviews, and decision discussions.
• Ensure outcomes and approved changes are reflected in plans and reporting.
• Prepare concise status updates for teams and leadership, highlighting milestones and risks.
• Design and maintain project databases, trackers, dashboards, and reporting processes.
• Consolidate data from multiple streams to identify trends and leadership focus areas.
• Improve program reporting efficiency, including automation of recurring data collection.

Skills

Project management

Stakeholder management

Risk management

Analytical thinking

Communication

Excel

Power BI

Planning

Education

Bachelor's degree in business/science/engineering/related field

Tools

Excel

Power BI

SharePoint

Job description

Job Location - 155 N. McCarthy BLVD, Milpitas, California, United States of America, 95035

Contract- 12 Months || Onsite

Job Description -

We are seeking an experienced Senior Project/Program Manager to support a major global regulatory registration and product transition program, along with other strategic integration initiatives within the Biosciences organization.

Functional subject matter experts will own and perform the underlying regulatory, quality, technical, labeling, operational, commercial, and IT work. The Senior Project/Program Manager will integrate these activities into an executable plan, track progress, manage dependencies and risks, and drive timely decisions and accountability across the team.

The successful candidate will be 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.

Key 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 that align 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 completion of deliverables in a matrix environment.
• Identify and manage risks, issues, actions, decisions, assumptions, schedule conflicts, and resource constraints.
• Assess the downstream impact of changes and delays, establish mitigation plans with accountable owners, and escalates 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 appropriate 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 opportunities to simplify or automate recurring data collection.

Required Qualifications-

• 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 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.

Preferred Qualifications-

• 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.
• Independently structures ambiguous work and drives it to completion.
• Balances detailed workstream execution with broader program priorities and changing requirements.
• Translates project data into clear insights, decisions, and actions.
• Uses sound judgment in issue resolution, escalation, and prioritization.
• Manages multiple priorities effectively in a fast-moving environment.
• Maintains high standards for detail, data quality, and reporting accuracy.