Head Quality Systems & Compliance (m/w/d)

at  Lonza

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.
In this role of responsibility, you will lead the Quality Systems and Compliance organization for an exciting joint-venture, implementing Quality Systems capabilities that translate the quality strategy of Lonza and support the success of the assigned investment projects.
Your out of the box thinking skills will help your team to continuously improve processes, ensuring our high quality standards are met.

Your tasks:

• Establish a team of Quality Systems & Compliance managers/specialists and provide leadership to the team. Ensuring that your team receives training and supervision, working cooperatively with the leadership team to achieve quality and compliance goals
• Manage all Quality Systems & Compliance activities, supporting the development of the overall quality strategy for the site
• Maintain and monitor the processes for Document Management, Change Control, Deviation and CAPA Management, Inspections and Audits. Act as the lead SME for Quality/GMP compliance issues
• Ensure that regular assessments of the compliance and effectiveness of the Quality System requirements are performed and the results are reported to the leadership team
• You will champion continuous improvements efforts to establish an effective and efficient Quality Management System in compliance with cGMP guidelines and corporate requirements
• Coordinate and manage customer audits and health authority inspections (e.g. Swissmedic, FDA, etc.). Ensure that primary responsibilities of Quality & Compliance are executed in line with corporate requirements, industry best practices and current regulatory requirements (cGMPs)
• Implement the Lonza culture via openness for innovations and change, cooperative teamwork and continuous improvement even outside your own area of responsibility. Support and implement a vision as important contributor to the organizations success

What you bring to the role:

• Bachelor or Master in Science or Engineering
• Several years of experience in the area of pharmaceutical manufacturing, preferably in a Quality & Compliance function
• Strong background in cGMPs and Quality Management Systems
• Very good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies
• Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive – you enjoy supporting and motivating your team
• Sound experience in representing Quality and Compliance in large investment projects, from planning to successful health authority inspections.
• Fluency in English is a must, fluency in German is 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

Your tasks:

• Establish a team of Quality Systems & Compliance managers/specialists and provide leadership to the team. Ensuring that your team receives training and supervision, working cooperatively with the leadership team to achieve quality and compliance goals
• Manage all Quality Systems & Compliance activities, supporting the development of the overall quality strategy for the site
• Maintain and monitor the processes for Document Management, Change Control, Deviation and CAPA Management, Inspections and Audits. Act as the lead SME for Quality/GMP compliance issues
• Ensure that regular assessments of the compliance and effectiveness of the Quality System requirements are performed and the results are reported to the leadership team
• You will champion continuous improvements efforts to establish an effective and efficient Quality Management System in compliance with cGMP guidelines and corporate requirements
• Coordinate and manage customer audits and health authority inspections (e.g. Swissmedic, FDA, etc.). Ensure that primary responsibilities of Quality & Compliance are executed in line with corporate requirements, industry best practices and current regulatory requirements (cGMPs)
• Implement the Lonza culture via openness for innovations and change, cooperative teamwork and continuous improvement even outside your own area of responsibility. Support and implement a vision as important contributor to the organizations succes

What you bring to the role:

• Bachelor or Master in Science or Engineering
• Several years of experience in the area of pharmaceutical manufacturing, preferably in a Quality & Compliance function
• Strong background in cGMPs and Quality Management Systems
• Very good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies
• Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive – you enjoy supporting and motivating your team
• Sound experience in representing Quality and Compliance in large investment projects, from planning to successful health authority inspections.
• Fluency in English is a must, fluency in German is an advantag