Sr. Project Manager, RAQA What You’ll Do:
Lead medium to high complexity cross-functional RAQA projects from initiation through completion
Develop and maintain project plans, schedules, budgets, resource plans, communication plans, and related documentation
Partner with functional leaders to define project scope, objectives, deliverables, milestones, and success criteria
Coordinate activities across Regulatory Affairs, Quality Assurance, R&D, Operations, Supply Chain, Manufacturing, Clinical, Marketing, Finance, and external partners
Facilitate cross-functional meetings and ensure decisions, action items, risks, and dependencies are documented and managed
Monitor project progress and communicate status, risks, issues, and mitigation plans to stakeholders and leadership
Identify project risks and develop mitigation and contingency plans
Manage project scope, schedule, cost, and quality while balancing competing priorities
Drive resolution of project issues through collaboration across functional teams
Support implementation of new regulatory requirements, quality initiatives, remediation activities, product changes, and compliance projects
Ensure projects comply with internal quality system requirements and applicable global regulatory standards
Track project financials, including budget forecasts and actual expenditures
Support continuous improvement of project management processes, tools, and best practices
Provide coaching and mentoring to less experienced project managers and team members
Present project updates and recommendations to senior management and project sponsors
What You Bring:
Bachelor’s degree (BA/BS) or equivalent (emphasis in management or related discipline preferred)
PMP certification or equivalent (e.g., PRINCE2) preferred
Minimum of 7 years of project management experience, preferably within medical device, life sciences, pharmaceutical, or other regulated industry
Experience with quality systems, regulatory compliance, product development, or manufacturing projects preferred
Strong knowledg

Sr. Project Manager, RAQA

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Sr. Project Manager, RAQA

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