Associate Director, Quality Assurance & Transformation

Lonza; Bend, Northern (OR, KY); Hybrid; Confidential; Full time

Benefits offered by this job

Medical, dental, vision

Relocation assistance

Career development

Global exposure

Job summary

Lonza is seeking an Associate Director of Quality Assurance (QA) Transformational Lead in Bend, Oregon. This site-based role champions a culture of proactive quality, continuous improvement, and data-driven practices across QA, Manufacturing, IT, and Supply Chain to ensure ongoing compliance with cGMP and global regulations.

The role focuses on redesigning core QA processes, aligning with FDA/EMA/ICH guidelines, and leading multi-site quality initiatives to improve efficiency and readiness for

Qualifications

• Bachelor's degree in Engineering or Life Sciences or related field.
• 10+ years of quality assurance experience within pharmaceutical, biotechnology, or related industry.
• Expertise in GMP/FDA regulations with proven track record managing quality systems, investigations, change controls, and CAPA.

Responsibilities

• Lead site-wide initiatives to shift the organizational mindset toward proactive quality and continuous improvement.
• Map, analyze, and redesign core QA processes to reduce cycle times.
• Align transformation strategies with FDA, EMA, and ICH guidelines for inspection readiness.
• Collaborate with global quality networks to standardize procedures across sites.
• Champion advanced QRM methodologies and data-driven risk assessments.
• Serve as the primary liaison between QA, Manufacturing, IT, and Supply Chain.
• Establish, track, and report KPIs and data maturity models.

Skills

Quality Assurance

GMP Compliance

Stakeholder Collaboration

Change Management

Data-driven QA

Education

Bachelor's degree in Engineering

Job description

Lonza is seeking an Associate Director of Quality Assurance (QA) Transformational Lead in Bend, Oregon. This site-based role champions a culture of proactive quality, continuous improvement, and data-driven practices across QA, Manufacturing, IT, and Supply Chain to ensure ongoing compliance with cGMP and global regulations.

The role focuses on redesigning core QA processes, aligning with FDA/EMA/ICH guidelines, and leading multi-site quality initiatives to improve efficiency and readiness for