Job Title: Senior Quality Assurance Professional
We are seeking a seasoned quality assurance professional to drive our quality strategy and ensure compliance with regulatory requirements.
As a key driver of quality assurance activities, you will oversee the alignment of all operations with current Good Manufacturing Practices (cGMP) principles and regulatory expectations from agencies such as the FDA and EMEA.
Key Responsibilities:
* Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP 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 site 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.
Qualifications and Experience:
* 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.
* Strong written and verbal communication skills, capable of clearly articulating complex quality issues.