We are seeking an experienced Project Manager Consultant for a short-term contract position ending in March. This role will focus on providing comprehensive coordination and oversight for a project, ensuring compliance and operational efficiency within a regulated environment.

Responsibilities

• Oversee and manage the scope, planning, and execution of assigned projects to ensure timely completion and adherence to objectives.
• Contribute hands-on to updating Standard Operating Procedures (SOPs) and Quality/Service Contracts, ensuring compliance with industry standards.
• Manage the development and integration of Process Validation (PV) and Test Method Validation (TMV) for external services.
• Prepare and deliver Subject Matter Expert (SME) training sessions to ensure readiness for FDA audits.
• Provide regular updates to management, highlighting project progress, risks, and corrective actions.
• Support FDA audits with expertise and experience in regulatory compliance.

Qualifications

• Bachelor's degree in science or engineering.
• Experience in project management within regulated industries such as medical devices, pharmaceuticals, or biotechnology.
• Knowledge of Process Validation (PV) and Test Method Validation (TMV).
• Proven ability to update SOPs and Quality/Service Contracts effectively.
• Prior experience with FDA audits is strongly preferred.
• Strong organizational, communication, and problem-solving skills.

Location

• San Jose, CA

Employment Type

• 1099

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled