Program Manager – Regulated Systems Delivery

Program Manager – Regulated Systems Delivery

Program Manager – Regulated Systems Delivery

Direct message the job poster from Master Compliance

Program Manager – Regulated Systems Delivery

Duration: 7 Months

Work Arrangement: Remote (Local candidates preferred and prioritized) - MA

Hours/Week: 40

Position Summary

Our client is seeking two highly experienced Senior Agile Program Managers to oversee complex, cross-functional systems initiatives across regulated business units. This role requires end-to-end program oversight, with a strong emphasis on Agile/SAFe methodologies, regulated environments (CSV/QMS), and technical solution delivery across software, hardware, and infrastructure landscapes. You will play a hands-on leadership role, driving the execution and governance of enterprise-scale releases across Agile Solution Delivery trains.

Key Responsibilities

• Drive strategic program delivery from planning through execution, supporting large-scale solution releases across multiple Agile Release Trains (ARTs).
• Own and maintain integrated project plans, Gantt charts, and RAIDE registers, aligned with Agile PI Plans and system milestones.
• Facilitate steering committee and cross-functional core team meetings, driving alignment on program scope, timelines, and risks.
• Guide teams in adherence to Computer Systems Validation (CSV) and Quality Management System (QMS) procedures.
• Proactively identify and mitigate program risks, issues, and cross-functional dependencies.
• Support change impact analysis, scenario planning, and cross-team collaboration.
• Collaborate with Product Owners and ARTs during PI Planning and influence planning outcomes.
• Ensure alignment with regulatory compliance standards and corporate quality policies.
• Travel domestically/internationally as needed.

Decision-Making Authority

• Influence long-term program roadmaps (24-month horizon) and integrated release schedules.
• Lead escalation and resolution of high-impact program risks and cross-functional blockers.
• Support budget alignment, change control, and communication of critical program changes.

Required Skills and Experience

• 10+ years of total experience , including 5+ years leading cross-functional programs/projects .
• Proven experience with Agile/SAFe frameworks – SAFe certification required .
• Background in managing programs involving infrastructure, software, hardware, or cloud-based technologies .
• Deep understanding of regulated environments , including Computer System Validation (CSV) and QMS principles .
• Strong project management skills – PMP or similar certification preferred.
• Advanced proficiency in PM tools : MS 365 Suite (Excel, Project, PowerPoint, Outlook, Teams), SharePoint, Smartsheet, Miro.
• Demonstrated ability in stakeholder management, communication, and leadership .

Preferred Technical Exposure

• Agile Toolsets : Jira, Confluence
• CRM Systems : Salesforce, Marketing Cloud
• ERP Platforms : SAP
• Integration Tools : Mulesoft
• Product Lifecycle/Quality Systems : Arena (PLM/QMS)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Project Management, Health Care Provider, and Product Management

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

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