Senior Quality Assurance Manager
We are seeking a highly skilled and experienced Senior Quality Assurance Manager to oversee quality assurance activities in our organization. As a key driver of quality, you will ensure that all operations align with regulatory expectations and industry best practices.
* Lead the review and approval process for change controls, deviations, SOPs, and related documentation to guarantee full compliance with GMP principles and site-specific requirements.
* Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
* Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
* Assist in developing and maintaining QA policies, SOPs, and reports that support organizational operations and compliance.
* Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
* Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
* Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.
Requirements:
* Bachelor's degree in Science, Quality, or a related technical field.
* 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within regulated environments.
* Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms.
This is an excellent opportunity to join a leading organization and contribute to its success.