Director, Quality Engineering & Computer System Assurance
seranbio· Commercial Manufacturing
About this role
Serán BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization’s validation, qualification, and computerized systems assurance programs. This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.
This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.
The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.
Frequently Asked Questions
Is the salary disclosed for the Director, Quality Engineering & Computer System Assurance position at seranbio?
The salary for this Director, Quality Engineering & Computer System Assurance role at seranbio is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Director, Quality Engineering & Computer System Assurance position at seranbio located?
This Director, Quality Engineering & Computer System Assurance role at seranbio is based in Bend, Oregon. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Director, Quality Engineering & Computer System Assurance role at seranbio full-time or part-time?
This is listed as a Full time Exempt position. It is posted as a Director, Quality Engineering & Computer System Assurance role in the Commercial Manufacturing department at seranbio.
Which team or department does the Director, Quality Engineering & Computer System Assurance at seranbio belong to?
This Director, Quality Engineering & Computer System Assurance position is part of the Commercial Manufacturing department at seranbio. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Director, Quality Engineering & Computer System Assurance position at seranbio?
Click the "Apply Now" button on this page. You will be redirected to seranbio's official application portal hosted on lever where you can submit your application directly.
When was the Director, Quality Engineering & Computer System Assurance job at seranbio posted?
This Director, Quality Engineering & Computer System Assurance position at seranbio was posted on Apr 14, 2026. Apply as soon as possible — early applications are often reviewed first.
Director, Quality Engineering & Computer System Assurance
seranbio
You'll be redirected to seranbio's official application page on Lever.