We are seeking a skilled professional to fill the role of Quality Assurance Lead. As a key driver of quality assurance activities at our site, you will be responsible for ensuring that all operations align with cGMP principles and regulatory expectations.
In this challenging position, you will lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation. You will also manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
Your expertise in quality management systems such as Veeva, SAP, PAS-X, or similar platforms will enable you to effectively monitor and evaluate new regulatory guidance and industry best practices.
Responsibilities:
1. Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation.
2. Manage QA operational duties related to product disposition.
3. Monitor and evaluate new regulatory guidance and industry best practices.
4. Develop and maintain QA policies, SOPs, and reports.
5. Champion continuous improvement initiatives.
6. Participate in risk management activities.
7. 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.