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.

Participate in the day-to-day Quality and Regulatory needs related to Lonza’s Strategic Growth Investments in the assigned network (Large CAPEX projects > 5 mCHF) for the phase “Ideation”, “Feasibility”, “Concept Design”, “Basic Design”, and through Qualification activities. Responsible for day-to-day Quality and Regulatory aspects of both large (> 5 mCHF), and small CAPEX projects, where required, during the execution stage and support the sites and project team as required.  This will require both remote work, and travel, as project needs dictate. Responsible for ensuring that decisions are fully supported by global and local Quality and Regulatory. Escalating issues in an open and timely manner and taking leadership for their resolution. Drives efficiency of the QA/regulatory approach across the assigned network project portfolio.

Key responsibilities:

• Ensure that strategic growths projects are in compliance with current Quality and Regulatory guidelines. Detect potential gaps and initiate corrective and preventive actions (continuous improvement).




• Responsible for projects at sites in the Americas, as needed.  Flexibility to travel and remote work are required.




• Ensure that decisions are fully supported by Lonza Global Quality as well as local Quality and Regulatory organizations.  Must be able to build relationships with local Quality organizations.




• Support the quality strategy for Strategic Growth Investments and Engineering (SGIE) group which is aligned with Quality and Regulatory guidelines and entrepreneurial approaches.




• Support SGIE in business related quality and compliance topics, including risk management.




• Facilitate the deployment of the quality strategy as approved by top management within SGIE




• Support sites in the collaboration with authorities and customers which are linked to strategic growth projects.




• Provide expertise and coaching, assisting sites and their teams for policies, procedures and specifications as they align to Corporate Standards.




• Contribute to the development and maintenance of global and local quality systems in line with current regulatory requirements. Ensure collaboration with other Lonza Quality, Regulatory, SGIE and Operations functions with the goal to share best practices and to have one global quality system, wherever applicable.

Key requirements:

• Bachelor’s Degree




• Substantial relevant experience in a regulated pharmaceutical industry including engineering, manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs.




• Experience of chemical and biological GMP API manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements.




• Proven management experience in an EMA / FDA regulated environment, and have an excellent working knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.




• Experience in QA aspects of facility design to build a compliant but cost effective plant (area classification, CQV requirements etc.)




• Experience in execution of large Capital projects




• Participation role in operations readiness, the bridge between project execution and handover to Operations.




• Experience in presenting during USFDA, EMA, MHRA Audits etc. is a plus




• Excellent communications skills, both written and verbal, and knowledge of computer systems (i.e. Microsoft Word, Excel, PowerPoint, and Visio).  Also demonstrated skills in the use of information management systems in a GxP environment (TrackWise, DMS, LIMS, SAP etc.).




• Working knowledge of modern approaches to compliance such as cGMP in the 21st century.




• Working knowledge of modern quality tools such as risk based approaches – FMEA, statistical process control, design of experiments and Six Sigma.




• Profound working knowledge of cGxP regulations and regulatory trends as they pertain to the stated responsibilities

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.