ProjectProgram Mgmt Spec 2

On site preferred but for a stellar candidate we can do remote

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

• Bachelors 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.