Job Title: Senior Quality Assurance Expert
The ideal candidate for this role will be responsible for ensuring the highest standards of quality in our organization. As a key driver of quality assurance activities, you will lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and regulatory expectations.
This position requires a highly skilled individual with a strong understanding of quality management systems such as Veeva, SAP, PAS-X, or similar platforms. You will also be responsible for monitoring and evaluating new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
We are seeking an experienced professional with a degree in Science, Quality, or a related Technical field, who has 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
About This Role
* Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation.
* Manage QA operational duties related to product disposition.
* Monitor and evaluate new regulatory guidance and industry best practices.
* Assist in developing and maintaining QA policies, SOPs, and reports.
* Champion continuous improvement initiatives.
* Support and execute the internal audit program.
Requirements
* Degree in Science, Quality, or a related Technical field.
* 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
* Hands-on experience with quality management systems.
We offer a dynamic and supportive work environment that encourages growth and development. If you have a passion for delivering high-quality products and services while upholding the highest standards of quality and regulatory adherence, we encourage you to apply for this exciting opportunity.