Associate Director, Quality Assurance

Lonza • Bend, OR

6d • Onsite

About The Position

The Associate Director, Quality Assurance will provide strategic quality leadership at the Bend site. In this role, the individual will lead critical quality programs, develop high-performing teams, and help ensure the delivery of life-changing therapies that positively impact patients around the world. This is a fully site-based role, emphasizing close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

Requirements

• Bachelor's degree in engineering, life sciences, or a related field.
• 10+ years of quality assurance experience within the pharmaceutical, biotechnology, or related industry.
• Experience leading quality teams and developing high-performing employees.
• Strong knowledge of GMP regulations and pharmaceutical manufacturing operations.
• Experience with FDA regulations, including CFR Parts 11, 210, 211, and 820.
• Proven ability to manage quality systems, investigations, change controls, and CAPA programs.
• Strong communication, collaboration, and problem-solving skills.

Responsibilities

• Lead and oversee the site's Quality Assurance Management System to ensure compliance with regulatory and corporate requirements.
• Serve as the primary Quality Assurance contact for site quality systems and quality-related activities.
• Oversee investigations, change controls, and CAPAs to ensure timely and compliant execution.
• Lead, coach, and develop Quality Assurance team members to build a high-performing organization.
• Support client and regulatory audits and help maintain an inspection-ready environment.
• Partner with clients, project teams, and site stakeholders to drive quality initiatives and achieve business objectives.
• Lead risk-based quality strategies and continuous improvement projects that support operational excellence.

Benefits

• Relocation assistance is available for eligible candidates and their families, if needed.
• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Medical, dental, and vision insurance.
• Opportunities to lead and develop talented quality professionals.
• Exposure to cross-functional and global quality initiatives.
• Access to Lonza's comprehensive benefits programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager