QA Manager Operations DPS Growth Project 80-100% (m/f/d)
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.
Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position QA Manager Operations DPS Growth Project (m/f/d) 80-100% being responsible for a new sterile Drug product facility in a Capital investment project. The primary purpose of the role is to ensure a Right First Time in Inspection Readiness for a Big CAPEX Project (encompassing a Fill Finish Facility, Laboratories, Warehousing, Shipment, and Offices). The Incumbent will prepare for and drive all Quality Elements defined in the Operational Readiness Strategy, align with the global DPS, Quality Management, MSAT, and Engineering
Key responsibilities:
Defining the framework for the documentation management system and all related Quality Management Systems
Designing, facilitating and executing, the overall Contamination Control Strategy for the project and defining a life cycle management approach inline with progression of the project and global implementation
Ensuring the Facility Design will meet the endpoints of a highly efficient, state of the Art, compliant Facility meeting current and future expectations from customers and regulators
Supporting and advising on the execution of Quality Standards
Develop and Lead the implementation of the Quality Management System (specifically Document Management System) for the Big CAPEX Project
Ensure consistency of Design Decisions with URS and respective Risk Assessment, define a holistic review mechanism in collaboration with assigned Q project lead
Initiate the design of a contamination control strategy inline with regulatory expectations and ensure a life cycle management inline with global standards / project progression
Key requirements:
Master’s Degree or equivalent experience in Quality Management, Life Science, Pharmaceutical Sciences, or related science discipline
Extensive experience in a regulated pharmaceutical, biotechnical industry, specifically in Quality Management as well as related functions such as manufacturing, MSAT, engineering, regulatory affairs, which includes eligibility to act as a FvP / RP inline with Swiss regulations
Experience of chemical and biological GMP API, aseptic Drug Product Manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements
Knowledge in designing and executing Quality Management Systems and providing Quality Oversight to Big CAPEX Projects ensuring an on-time Inspection Readiness
Experience in organizing and hosting regulatory inspections
Fluency in German and English is required
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.