Senior QA Leader — Onsite GMP, Bend, OR

Lonza; Bend (OR); On-site; Confidential; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Opportunities for leadership growth

Global Lonza benefits access

Recognition programs for performance

Inclusive and ethical workplace

Career development support

Job summary

Lonza in Bend, Oregon, is seeking a site‑based Quality Assurance leader to drive regulatory compliance and reinforce quality systems across GMP production and documentation processes.

You will lead QA teams, collaborate with manufacturing and development, and ensure adherence to internal standards and external inspections. Strong GMP knowledge, leadership, and communication are essential for success in a fast‑paced, regulated environment.

Qualifications

• Bachelor’s degree or equivalent experience in a relevant field.
• Extensive experience in the pharmaceutical industry, including work in CDMO environments.
• Proven leadership experience managing teams in regulated quality environments.
• Experience supporting or leading regulatory inspections and audits.
• Strong knowledge of GMP and quality systems.
• Excellent communication skills with the ability to engage diverse stakeholders.
• Ability to manage multiple priorities and drive results in a fast‑paced environment.

Responsibilities

• Lead Quality Assurance functions, including training, quality systems, and audit readiness.
• Manage and develop QA teams supporting GMP production and documentation processes.
• Ensure quality systems remain compliant, effective, and aligned with business needs.
• Support manufacturing and development teams to meet regulatory and internal standards.
• Review and approve quality documents, procedures, and specifications.
• Oversee deviation management, CAPA processes, and stakeholder communication.
• Support internal audits, client audits, and regulatory inspections.

Skills

QA Leadership

GMP/Regulatory Knowledge

Audit Management

Team Leadership

Documentation Control

Education

Bachelor's degree or equivalent

Job description

Lonza in Bend, Oregon, is seeking a site‑based Quality Assurance leader to drive regulatory compliance and reinforce quality systems across GMP production and documentation processes.

You will lead QA teams, collaborate with manufacturing and development, and ensure adherence to internal standards and external inspections. Strong GMP knowledge, leadership, and communication are essential for success in a fast‑paced, regulated environment.