Associate Director, Quality Assurance

About the role

The Associate Director, Quality Assurance role is based in Bend, Oregon (USA). Relocation assistance is available for eligible candidates and their families.

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.

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.

Qualifications

• Strong leadership and team management skills.
• Ability to work independently and as part of a team.
• Excellent interpersonal and communication skills.
• Knowledge of quality management systems and processes.

Skills

• Quality assurance experience.
• Leadership and team management skills.
• Collaboration and problem-solving abilities.
• Knowledge of GMP regulations and pharmaceutical manufacturing operations.
• Experience with FDA regulations.

Benefits

• 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.

Pay

Competitive compensation package.

Schedule

Full-time position.