About the job
Join Serán BioScience as the Director of Quality Engineering & Computer System Assurance (CSA), where you will play a pivotal role in steering the organization’s validation, qualification, and computerized systems assurance programs. This leadership position is crucial for supporting Good Manufacturing Practices (GMP) across our manufacturing, laboratory, and quality systems, encompassing both clinical and commercial operations.
Your responsibilities will include establishing a robust risk-based validation and CSA framework, ensuring that our facilities, utilities, equipment, analytical methods, processes, and computerized systems are maintained in a validated state throughout their lifecycle. You will ensure compliance with FDA, EU, and international regulatory requirements, including current Good Manufacturing Practices (cGMP), GAMP guidelines, and data integrity expectations.
In collaboration with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations, you will ensure that our validated systems and processes facilitate the safe, compliant, and reliable manufacturing of our clinical and commercial products. Additionally, you will act as a key quality leader during regulatory inspections, client audits, and internal quality reviews, driving continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.