Spec 2, Project/Program Mgmt

Bill is ***-*** .Pst hours preferred at least 10 years experience On site preferred but for a stellar candidate we can do remote Bill is up to *** based on experience. Experience with Acquisitions and Mergers, working with large global teams . PMP certification Experience with Product Registration, Labeling and Regulatory Submissions,
Senior Project/Program Manager (Contractor)

Location: Milpitas, California preferred. Remote candidates may be considered based on experience and qualifications.
Assignment Type: Temporary / Contract
Department: Biosciences Integration PMO
Reports To: Director, Integration Program Management

Position Summary

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 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 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.

Core Capabilities

• 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.