Quality Control Project Manager II

Today, Lonza is a global leader in life sciences operating across three 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 to 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 to be part of.

The QC Project Manager Level II is assigned as the primary liaison to an external customer(s) for all QC related items including temporary and permanent change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews, and GMP Records. Responsible to facilitate discussions between customers and internal groups such as QC, PV, MSAT, Manufacturing, Engineering and QA! For these quality-related items, the Project Manager coordinates the process for advising the customer and assuring the customer’s feedback and comments are addressed, verifies that the quality records are complete; that there is sound justification/scientific rationale; supports root cause analysis and identification of corrective and preventive action. Where applicable, the Program Manager assists in acquiring customer approval. The QC Project Manager leads Analytical Project Team meetings –establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the QC representative and tracks and publishes monthly and quarterly quality KPIs!
 

Key responsibilities:

• Manage multiple complex customer project teams as the Quality Control representative.

• Interpret analytical reports and effectively communicate content to external and internal collaborators.

• Coordinate efforts between manufacturing, customer, and Quality Control to prioritize and complete testing on time.

• Develop, revise, and review Good Manufacturing Practices (GMP) documentation, including specifications, protocols, and reports.

• Review and approve various product-specific documents such as batch records, sample plans, and sample maps.

• Collaborate with QC leaders, other departments, and customers to build an achievable work schedule and ensure agreed-upon timelines are met.

• Assist with onboarding and the training and development of new team members.

• Interact with internal and external customers as part of Joint and Internal project Teams, serving as the QC Subject Matter Expert.

• Measure appropriate metrics and report them to management.

• Initiate and drive quality records, such as change controls, investigations, deviations, CAPAs, etc.

• Apply Data Integrity principles in all aspects of work, adhering to Lonza DI policies, guidelines, and procedures.

• Work independently to drive tasks to completion.
   

Key requirements:

• Bachelor’s Degree in Microbiology, Biochemistry, or an equivalent science field.

• Minimum 5 years of experience within the GMP/GLP industry, with experience in a QC laboratory or QC setting.

• Minimum 2-5 years of experience managing projects.

• Experience using GMP Quality Systems (e.g., TrackWise, LIMS).

• Excellent interpersonal skills with the ability to collaborate across multiple teams and projects.

• Ability to exercise judgment within defined practices and policies to select methods and techniques for acquiring solutions and taking appropriate actions.
   

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.