Associate Director, Quality Assurance, Transformational Lead

Lonza; Bend, Northern (OR, KY); On-site; 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

Associate Director, Quality Assurance, Transformational Lead

United States, Bend (Oregon)

The actual location of this job is in Bend, Oregon (USA). Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want you to be part of.

We're looking for an Associate Director, Quality Assurance (QA) Transformational Lead to champion a culture of continuous improvement by influencing cross-functional teams and stakeholders to embrace modern, data-driven quality practices. Through strategic leadership and relationship-building, this role inspires organizational alignment to deliver impactful process changes while ensuring unwavering compliance with cGMP and global regulatory standards.

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Medical, dental, and vision insurance.
• Exposure to cross-functional and global quality initiatives.
• Access to Lonza's comprehensive benefits programs.

What you will do:

• Lead site-wide initiatives to shift the organizational mindset toward proactive quality, continuous improvement, and a robust "Quality Culture."
• Map, analyze, and redesign core QA processes—such as deviations, change controls, and batch release to eliminate bottlenecks and reduce cycle times.
• Align all transformation strategies with current global regulations, including FDA, EMA, and ICH guidelines, ensuring a state of constant inspection readiness.
• Collaborate with global quality networks to standardize procedures across different manufacturing sites and eliminate localized process variances.
• Champion advanced Quality Risk Management (QRM) methodologies, integrating data-driven risk assessments into the daily manufacturing lifecycle.
• Serve as the primary liaison between QA, Manufacturing, IT, and Supply Chain teams to ensure unified execution of modernization projects.
• Establish , track, and report on key performance indicators (KPIs) and data maturity models to measure the financial and operational impact of QA changes.
• Design and deliver training programs that equip the quality and operations teams with the skills needed to operate new digital tools and agile workflows.

What we are looking for:

• Bachelor's degree in engineering, life sciences, or r elatedfield.
• 10+ years of quality assurance experience within the pharmaceutical, biotechnology, or related industry.
• Expertise in GMP/FDA regulations (including CFR Parts 11, 210, 211, and 820) with a proven track record managing quality systems , investigations, change controls, and CAPA programs within pharmaceutical manufacturing operations.
• Ability to build trust and open communication channels across traditionally siloed departments like Manufacturing, Supply Chain, and Maintenance.
• Capability to drive strategic quality initiatives and process changes in other departments without having direct managerial control over those teams.
• Expert navigation of friction when quality requirements clash with aggressive production deadlines or commercial goals .

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability,

Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.