Associate Director, Quality Compliance & Inspections

Serán BioScience; Bend (OR); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Life insurance

Employee assistance

Job summary

Serán BioScience seeks an Associate Director, Quality Compliance to lead the Quality Compliance program, ensuring adherence to GxP, client requirements and our QMS. You will own inspection readiness, regulatory inspection management, client audits, internal audits, supplier quality, management review and quality metrics.

You will partner with Manufacturing, QC, MSAT, Supply Chain, Regulatory Affairs and Engineering to drive a proactive quality culture, preparing for inspections and advancing

Qualifications

• Bachelor's degree in life sciences or related field and relevant industry knowledge.
• Minimum 8 years of pharmaceutical/biotech quality experience.
• Minimum 3 years of leadership in Quality Compliance or related areas.
• Experience supporting FDA/EU inspections and GMP requirements.
• Experience with electronic Quality Management Systems (eQMS).

Responsibilities

• Lead the site's inspection readiness program and sustain continuous readiness.
• Monitor regulatory expectations and assess impacts on the QMS.
• Conduct routine compliance assessments to identify gaps and improvements.
• Drive remediation of inspection observations and quality risks.
• Support compliance initiatives to maintain commercial manufacturing readiness.

Skills

Regulatory knowledge

Independent work

Time management

Communication skills

Interpersonal skills

Organizational skills

Analytical thinking

Leadership

MS Office

Education

Bachelor's Degree in Life Sciences, Chemistry, Microbiology, Engineering, Pharmacy, or related discipline

Advanced degree preferred

Tools

eQMS

Document control systems

Job description

Serán BioScience seeks an Associate Director, Quality Compliance to lead the Quality Compliance program, ensuring adherence to GxP, client requirements and our QMS. You will own inspection readiness, regulatory inspection management, client audits, internal audits, supplier quality, management review and quality metrics.

You will partner with Manufacturing, QC, MSAT, Supply Chain, Regulatory Affairs and Engineering to drive a proactive quality culture, preparing for inspections and advancing