Head of QA Mammalian Manufacturing

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.

Ibex® Solutions ( www.ibex.lonza.com ) is a modular build complex to develop and manufacture biological products. It enables companies to get access to a complete solution, gaining speed and achieving a simplified value chain. The Ibex® Complex is our contribution to the medicine of tomorrow and possibly the next step in your career? Start your career with Lonza today. Apply as Head of QA Mammalian Manufacturing (f/m/d)!The Role oversees all Quality related responsibilities for our Mammalian Business, which includes for example providing leadership to the Quality Resources within the Mammalian Business ensuring effectiveness of the Quality System, executing on quality and regulatory standards, as well as fostering a continuous improvement approach to Quality.

Key responsibilities:

• Leading and developing the Quality Team, specifically by ensuring workforce planning, and ensuring organizational readiness to absorb the growth curve inline with forecast

• Developing an effective and cohesive teamwork, fostering close collaboration with internal and external customers and stakeholders

• Supporting and maintaining robust and reliable product supply to our customers as well as ensuring an inspection readiness state for the site to meet expectations from customers and regulators

• Driving all essential duties to comply with Lonza’s Quality Systems as well as Quality Oversight for the Mammalian Manufacturing Site (such as releasing drug substance, approving all relevant documents, approving sample plans, specifications, validation documents, stability documents, and driving risk assessments, specifically compliance gap assessments)

• Driving a lean mindset and establishing mechanisms to continuous improvement initiatives are executed in line with plan

• Maintaining quality oversight for the Buffer Manufacturing Sector utilized for Mammalian Production

• Ensuring an appropriate governance for all critical systems / design criteria, which are co-shared with neighboring technologies / business units

• Ensuring all technologies related to cell banking are compliant with current quality regulatory guidance

Key requirements:

• University degree in pharmacy, engineering, chemistry, microbiology or related life sciences discipline, PhD is preferred

• At least 15 years working experience in the pharmaceutical industry with demonstrated capability in quality leadership roles (12-15 years)

• Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization

• Comprehensive knowledge and expertise of biological manufacturing processes as well as related quality and management processes and systems

• Experience in mammalian cell manufacturing specifically utilizing single use technologies is preferred

• Ability to drive transparent quality decision making based on comprehensive data driven risk assessments

• Fluent in German (C2) and English

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.