Job Details

The Senior Program Manager is responsible for leading complex product development and manufacturing programs. Acting as the primary client interface for program execution, this individual ensures programs are delivered within scope, schedule, and budget while meeting quality and regulatory requirements.

This role requires a hands-on leader who combines strong financial acumen, technical program management expertise, and client engagement skills. The Senior Program Manager will lead cross-functional teams across R&D, Operations, Manufacturing, Supply Chain, and Quality, driving program execution from initiation through closure. The position is accountable for project financial performance, proactive risk management, and fostering long-term client relationships by consistently delivering results.

Key Responsibilities

• Serve as the primary client contact throughout program execution
• Lead cross-functional teams through development, verification, transfer, and commercialization phases
• Develop and manage detailed project plans, schedules, and budgets
• Own program financial performance, including revenue, margin, forecasts, and change management
• Proactively identify and mitigate program risks; escalate issues as needed
• Report program status, financials, risks, and opportunities to clients and leadership
• Ensure compliance with QMS, design controls, and applicable regulatory standards (FDA, ISO)
• Support client audits and regulatory interactions
• Partner with Business Development on scope changes and new project scoping
• Contribute to PMO process improvement, standardization, and best practices

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field (advanced degree a plus)
• PMP certification strongly preferred
• 10+ years of program or project management experience in medical device, biotech, CDMO, or other regulated manufacturing environment
• Strong knowledge of regulated product development, NPI, and manufacturing processes
• Proven ability to manage complex schedules, budgets, and cross-functional teams
• Excellent client-facing communication, presentation, and stakeholder management skills
• Comfortable navigating ambiguity, driving decisions, and managing challenging conversations