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
Job function
Job function
Project Management, Health Care Provider, and Product ManagementIndustries
Pharmaceutical Manufacturing
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Inferred from the description for this job
Medical insurance
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