QA Operations Manager 80-100% (f/m/d)

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 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 role involves responsibility for Quality Assurance in the operational business of microbial manufacturing within one program, including the functional management of the QA staff assigned to this area. 

This area of responsibility includes the control and approval of all operational documents (e.g. SOPs), monitoring the technology transfer of the biotechnological process from the existing facilities, ensuring operational GMP readiness in the new program assets, and handling all quality assurance tasks for upcoming clinical and commercial production.

• An agile career and dynamic working culture

• An inclusive and ethical workplace

• Compensation programs that recognize high performance

• A variety of benefits dependant on role and location

• Functional management of one QA operations group within the manufacturing unit

• Responsibility for the QA Operations work of one technology platform

• Identify, assess and manage tasks that impact Quality operation during GMP manufacturing

• Support day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for a GxP contract manufacturing facility

• Review GMP records to ensure compliance with cGMP per written procedures (e.g., batch records, TW records, etc.)

• Make real-time decisions on process events on the floor, based on knowledge of defined SOPs & policies

• Participate in audit/inspections

• Identify potential for improvement in daily routine processes, develop and implement optimization options to improve the quality and efficiency of daily work

• Academic degree in Life Sciences or strong related working experience in QA Operations in the Biopharma environment

• Strong leadership skills, high willingness to take ownership/responsibility

• Knowledge of and experience in quality management systems in a GMP manufacturing environment

• Hands-on experience in coordinating & interacting with internal departments (Manufacturing, QC, Engineering, QSS, etc.)

• Excellent collaboration and communication skills at management level for risk identification and escalation/mitigation activities

• Depth knowledge and experience of facility start-up, technology transfer and routine manufacturing operation 

• Fluent English is required, good German skills - an advantage

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.