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Director, Quality Engineering & Computer System Assurance (CSA) at Serán BioScience - ApplyBlast

Director, Quality Engineering & Computer System Assurance (CSA)

Serán BioScience

6 months ago

3.8 on Glassdoor

Bend, Oregon, United States

Onsite

Full Time

Director

0 applicants

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About this role

The Director, Quality Engineering & Computer System Assurance (CSA) leads strategic and operational validation, qualification, and computerized systems assurance programs for GMP manufacturing, laboratory, and quality systems across clinical and commercial operations. This role ensures compliance with FDA, EU, and international regulations, partners with cross‑functional teams, and drives continuous improvement in validation lifecycle management and data integrity.

Responsibilities

Develop and implement site strategy for Quality Engineering and CSA programs
Provide oversight of validation lifecycle and computerized system assurance
Lead and develop high‑performing Quality Engineering and CSA team

Skills

Qualifications

Bachelor's degree in a scientific disciplineAdvanced degree (Masters or higher)

About Serán BioScience

seranbio.com

Headquarters

Bend, Oregon, United States

Company Size

201-500 employees

Founded

2016

View Profile

Serán Bioscience is a science-driven drug development company that uses a research-first approach and advanced drug‑delivery technologies to enable and enhance clients’ medicines. They partner with biotech and pharmaceutical teams to translate therapies from concept toward clinical readiness, focusing on formulation and delivery solutions that improve patient outcomes. Headquartered in Bend, Oregon, Serán emphasizes rigorous science and collaborative development to accelerate programs and de‑risk therapeutic candidates.