Associate Director, Quality Compliance & Inspection Readiness

Serán BioScience; Bend (OR); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Life insurance

Long-term disability

Job summary

Serán BioScience in Bend, Oregon seeks an Associate Director, Quality Compliance to lead the Quality Compliance program, ensuring adherence to cGMP regulations, client requirements, and QMS standards. This role owns inspection readiness, regulatory inspections, client audits, internal audits, supplier quality oversight, and quality metrics to drive continuous improvement.

You will develop a high-performing Quality organization, mentor staff, manage inspection logistics, coordinate remediation,

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Microbiology, Engineering, Pharmacy, or related discipline.
• Minimum 8 years of pharmaceutical, biotechnology, medical device, or CDMO quality experience.
• Minimum 3 years of leadership experience within Quality Compliance, Quality Systems, or related quality functions.
• Experience in supporting FDA and / or EU regulatory inspections.
• Experience with electronic Quality Management Systems (eQMS).

Responsibilities

• Lead the site's quality compliance program and inspection readiness.
• Coordinate regulatory inspections and client audits.
• Oversee internal audit program and supplier quality.
• Develop metrics and management reviews for quality performance.
• Drive continuous improvement in cGMP compliance.

Skills

FDA regulations

cGMP knowledge

Leadership

Communication

Time management

MS Office

Education

Bachelor's Degree in Life Sciences or related

Advanced degree preferred

Tools

eQMS

Microsoft Office

Job description

Serán BioScience in Bend, Oregon seeks an Associate Director, Quality Compliance to lead the Quality Compliance program, ensuring adherence to cGMP regulations, client requirements, and QMS standards. This role owns inspection readiness, regulatory inspections, client audits, internal audits, supplier quality oversight, and quality metrics to drive continuous improvement.

You will develop a high-performing Quality organization, mentor staff, manage inspection logistics, coordinate remediation,