Director, Quality Engineering and Computer System Assurance

Job overview

Director, Quality Engineering and Computer System Assurance is an onsite role in Bend, OR. Compensation is not specified. The role supports GMP manufacturing, laboratory, and quality systems across clinical and commercial operations at Serán BioScience. The director leads validation, qualification, computerized systems assurance, and data integrity programs to keep facilities, equipment, processes, and systems in a validated state. The role partners across technical and quality functions and supports regulatory inspections, client audits, and continuous improvement.

What you'll do

• Set site strategy for Quality Engineering and CSA
• oversee validation lifecycle programs and documentation
• ensure computerized systems and data integrity meet regulatory expectations
• provide quality oversight for change control, deviations, CAPA, and risk assessments
• support projects and inspections
• lead and develop the Quality Engineering and CSA organization.

What we're looking for

Skills & competencies

quality engineering

computer system assurance

validation

gmp

data integrity

pharmaceuticals

leadership

bend or

serán bioscience

regulatory compliance

Work arrangement

• Weekend coverage required

Benefits & perks

• More than four weeks of paid time off annually
• employer retirement contributions after 90 days
• health plans with minimal employee contributions
• basic life and long-term disability coverage
• employee assistance program and pet insurance.

Why this role

Requires 10+ years of pharmaceutical or biotechnology GMP and quality experience, including 5+ years in qualification, validation, or CSA activities; the employer states it cannot sponsor employment visas.

About the employer

Serán BioScience is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.