Associate Director, 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.
This is a newly created role under the Quality SGIE (Strategic Growth Initiatives and Engineering) organization. This regional role requires the candidate to be directly responsible for small & large scale growth investment projects in Singapore and also provide secondary support to large scale growth investment projects in APAC/China.
Spectrum includes initiation/ideation phase, construction, testing + commissioning to qualification/validation of large scale complex systems, GMP Commissioning & Facility Readiness, manufacture of 1st GMP Batches / Process Validation & Cleaning Validation.
- 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).
- 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.
- Facilitate 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 projects.
- Providing expertise and coaching, assisting sites and their teams for policies, procedures and specifications.
- Help manage 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.
- Master Degree or equivalent in Quality Management, Engineering or related Science discipline.
- Significant 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.
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 achieve 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.