Consulting Study Director

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry.

With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality.

We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Job Summary

The Consulting Study Director is a trusted advisor and consultative expert for clients and serves as the initial customer contact for validation studies, large projects, and other testing requiring a high degree of consultation.

The position requires the highest level of customer service and broad technical expertise.

The Consulting Study Director assists Sales with quote generation, develops test protocols, ensures testing setup is complete, and facilitates a smooth transition of projects to Production Study Directors.

This enables production teams to focus on testing while delivering an exceptional client experience.

The primary responsibility of this role is to help clients plan and organize projects through specialized expertise, high availability, and a high-touch customer service approach.

Essential Job Functions

Study Consulting



* Demonstrate deep understanding of industry regulations, standards, and guidelines (GMP, GLP, FDA, AAMI, ISO, ASTM, USP, etc.).


* Collaboratively develop test protocols and testing strategies to meet client expectations.


* Partner with Production Study Directors to ensure seamless project handoffs.


* Assist clients and production teams with unexpected or unique testing challenges.


* Coordinate technical consulting activities including summary protocols, written justifications, sample plan justifications, risk assessments, and special projects.

Customer Focus



* Provide exceptional customer service.


* Maintain extensive client phone contact.


* Build strong relationships with clients, Sales, Service Center, and Production Study Directors.

Regulatory Compliance



* Follow applicable regulatory requirements (GMP, GLP, ISO, etc.).


* Stay current on regulatory trends.


* Follow company policies and procedures.

Professional Development



* Complete required training on time.


* Stay current on scientific literature, test methods, and best practices.


* Perform other duties as assigned.

Job Requirements



* Excellent internal and external customer service skills.


* Stron...