Senior Manager, Quality SGIE
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.
Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market.
Senior Manager, Quality SGIE is to participate in the day-to-day Quality and Regulatory needs related to Lonza’s Strategic Growth Investments in the assigned network.
- Understand the purpose of the assigned experiment, and perform efficiently the experimental plan to get the results in timely, accurate and detailed way.
- Implement strategic growths projects in compliance with current Quality and Regulatory guidelines. Detect potential gaps and initiate corrective and preventive actions (continuous improvement).
- Make sure that decisions are fully supported by Network Lead, Lonza Global Quality as well as local Quality and Regulatory organizations.
- Support the quality strategy for SGIE which is aligned with Quality and Regulatory guidelines and entrepreneurial approaches
- Support SGIE in business related quality and compliance topics, including risk management.
- Participate in the deployment of the quality strategy as approved by top management within SGIE
- Supporting the sites in the collaboration with authorities and customers which are linked to strategic growth project
- Providing expertise and coaching, assisting sites and their teams for policies, procedures and specifications.
- Co-ordinate and support required QA/ RA resources (and proper expertise) at the sites in order to properly support strategic growth projects.
- Contributing 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, where applicable
- Bachelor or above, majoring in Quality Management, Engineering or related Science discipline
- Extensive 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 of execution of large projects
- Participation role in operations readiness Experience in managing USFDA, EMA, MHRA Audits etc
- Excellent knowledge of computer systems (i.e. Microsoft Word, Excel, PowerPoint, and Visio) with 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 Skills
- Strong verbal and written communication skills.
- Effective influencing skills. Ability to communicate quality and compliance requirements to varying levels and functions of the organization
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.