Quality Assurance Systems Specialist (Deviation Investigator Level II)

Deviation Investigator Level II

We are seeking a dedicated Deviation Investigator Level II to join our Quality Operations team. In this role, you will lead root cause investigations, determine product quality impacts, and implement corrective actions to support the safe manufacturing of life-changing medicines.

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.

What you will do:

• Initiate, investigate, and complete Minor and low/medium severity Major process deviations unassisted; complete high severity Major and Critical deviations under supervision to identify root causes and prevent recurrence.

• Gather data from site-wide sources, perform Root Cause Analysis (RCA), assess events for impact to Safety, Identity, Strength, Quality, and Purity (SISQP), run trending analyses, and conduct risk assessments and cause mapping.

• Manage multiple project timelines concurrently, adhere to standard execution schedules, and escalate blockers appropriately for timely resolution.

• Work directly on the manufacturing floor to gather data, observe processes, and conduct associate interviews.

• Facilitate cross-functional alignment meetings, CAPA discussions, and comment resolutions while actively participating in or leading daily management updates and Deviation Review Boards (DRB).

• Routinely interact with customers by compiling presentations to communicate current investigation statuses and align on technical paths forward.

• Perform other duties as assigned.

What we are looking for:

• Bachelor's degree in a scientific or engineering discipline (or equivalent practical experience).

• Proven experience initiating and leading deviation investigations within a regulated cGMP manufacturing environment.

• Demonstrated proficiency in Root Cause Analysis (RCA) tools (e.g., 5 Whys, Fishbone, Cause Mapping) and SISQP impact assessments.

• Ability to work comfortably on the active manufacturing floor for observational studies and interviews.

• Strong project management and time-management skills to lead multiple concurrent timelines and drive cross-functional conflict resolution.

• Excellent written and verbal communication skills, with experience facilitating cross-functional meetings and presenting to clients or internal stakeholders.

About Lonza

Founded in 1897 in the Swiss Alps, our business has embraced innovation and kept pace with a fast-changing world for more than 125 years.

We are the CDMO that opened the door to a new era of medicine – one where breakthroughs could be produced at scale and made available around the world. Our contributions have led the way in drug approvals in our industry.

The therapies we help bring to life reach up to 100 million people each year, and we contribute to around one in every ten medicines that are newly approved by the FDA.

Political, regulatory, or economic disruption in one region doesn’t put the brakes on our business as our global network of 30+ sites across five continents provides resilience against global instability.

We are a community of big thinkers and bold doers. We focus on what matters, and together we make it happen. We are constantly pushing ourselves to make things better, never stopping until we make it right.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, protected veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

At Lonza, we are committed to building an inclusive workplace where diverse perspectives are valued and respected. We believe that diversity strengthens our teams, drives innovation, and helps us better serve our employees, customers, and communities. Reasonable accommodations are available for qualified individuals with disabilities throughout the recruitment process.