Description
Overview
Our client is seeking a highly skilled and results-driven Senior Operations Project Manager to lead the strategic relocation of operations to a new facility. This role is pivotal in ensuring a seamless transition with minimal disruption to production, quality, and compliance. The ideal candidate will bring extensive project management expertise, cross-functional leadership, and a deep understanding of operational workflows within a regulated medical device environment.
Key Responsibilities
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Lead the end-to-end management of the operations transition project, overseeing all planning, execution, and post-move stabilization activities.
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Develop and maintain comprehensive project plans, timelines, budgets, and resource allocations to ensure milestones are met.
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Partner with cross-functional teams—including Manufacturing, Quality, Regulatory, Facilities, IT, R&D, HR, Finance, and Supply Chain—to ensure alignment and readiness across all departments.
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Proactively identify, assess, and mitigate project risks and issues, escalating when necessary to ensure project success.
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Ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements throughout the relocation process.
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Oversee equipment relocation, validation, and requalification activities in coordination with internal teams and vendors.
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Facilitate effective change management strategies and communication plans to maintain employee engagement and operational continuity.
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Provide regular project updates, dashboards, and performance reports to senior leadership and stakeholders, highlighting progress, risks, and corrective actions.
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Champion continuous improvement by documenting lessons learned and implementing best practices to inform future strategic initiatives.
Qualifications
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Bachelor’s degree in Engineering, Operations Management, or a related field.
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PMP certification required.
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Minimum 7 years of project management experience in a regulated manufacturing environment—medical device experience strongly preferred.
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Demonstrated success leading complex, cross-functional projects involving facility transitions or large-scale operational changes.
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Strong understanding of GMP, FDA, and ISO 13485 compliance standards.
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Exceptional communication, leadership, and stakeholder management skills.
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Ability to excel in a fast-paced environment with multiple priorities and changing business needs.