Senior Project Manager

Summary *** MUST HAVE MANUFACTURING EXPERIENCE***

• The Senior Project Manager drives the CDMO’s most critical, high‑impact initiatives, including medical‑device manufacturing site consolidations, M&A operational integrations, and the deployment of Manufacturing Execution Systems (MES).
• This role serves as the connective tissue between executive strategy, operational execution, and disciplined quality compliance within an ISO 9001 environment. The ideal candidate excels at navigating organizational change while also leading hands‑on technology and process integrations on the production floor—ensuring that strategic intent is translated into sustainable, compliant, and scalable operational outcomes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead end‑to‑end execution of strategic, cross‑functional initiatives, including medical device manufacturing site consolidations, M&A operational integrations, and MES deployments.
• Drive structured project governance, including charters, timelines, risk registers, resource plans, and executive reporting.
• Monitor project financials, including budget creation, cost tracking, and ROI validation.
• Manage complex stakeholder landscapes, bridging corporate leadership, engineering, operations, quality, supply chain, and external partners.
• Identify and mitigate operational, technical, and regulatory risks, escalating issues proactively, and driving corrective actions.
• Support due diligence and post‑acquisition integration planning, including capability assessments, process harmonization, and system alignment.
• Serve as the primary point of accountability for project outcomes, ensuring delivery on time, within scope, and within budget.
• Oversee technology integrations on the shop floor, including MES, equipment connectivity, data integrity, and workflow digitization.
• Identify and mitigate operational, technical, and regulatory risks, escalating issues proactively, and driving corrective actions.
• Support due diligence and post‑acquisition integration planning, including capability assessments, process harmonization, and system alignment.
• Serve as the primary point of accountability for project outcomes, ensuring delivery on time, within scope, and within budget.

EDUCATIONAL REQUIREMENTS, QUALIFICIATIONS, and TRAININGS

• Bachelor's degree in engineering, Life Sciences, Operations, or related field; master’s degree or MBA preferred.
• 8–12+ years of project management experience in medical device, CDMO, or regulated manufacturing environments.
• Demonstrated success leading large, complex, multi‑site initiatives, including technology deployments and organizational transformations.
• Strong understanding of ISO 9001, medical device manufacturing practices, and quality system expectations.
• Hands‑on experience with MES or other manufacturing digital systems, including implementation, validation, or integration.
• Proven ability to work across both strategic and tactical levels, from executive communication to shop‑floor problem solving.
• Formal project management certification (PMP, PRINCE2, or equivalent) is strongly preferred.
• Experience relocating production lines and equipment in a controlled environment preferred.
• Experience with M&A integration, due diligence, or operational consolidation projects.
• Exceptional communication, facilitation, and stakeholder‑management skills, including executive‑level reporting.
• Strong analytical and risk‑management capabilities, with demonstrated use of structured methodologies.
• Knowledge of Lean, Six Sigma, or continuous improvement tools; certification is a plus.
• Ability to thrive in a small-company environment, balancing structure with agility and resource constraints.

COMPUTER AND SOFTWARE REQUIREMENTS

• Microsoft Office Suite (e.g. SharePoint, Teams, Excel, Word, PowerPoint).
• ERP/MRP, QMS, and document control systems.
• Project management tools (e.g., Microsoft Project)
• Ability to operate media equipment such as tablets, smartphones, and other electronic equipment.
• Ability to work with general office equipment.
• Ability to work with and understand databases a must and the ability to learn technical skills.

The qualifications, physical demands, and work environment described herein are representative of those an employee will encounter and must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

This document does not create an employment contract, implied or otherwise, other than an "at will" relationship .

The above noted job description is not intended to describe, in detail, the variety of tasks that may be assigned but rather to give the incumbent a general sense of the responsibilities and expectations of his/her position. As the nature of business demands change, so, too, may the essential functions of this position