Job Detail

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

The Head of Quality, Strategic Growth Investments & Engineering is a new opportunity at Lonza. This position is responsible for all Quality and Regulatory aspects related to Strategic Growth Investments. It is a key position working with both leadership Quality organization and local Quality and Regulatory groups. The Head of Quality, Strategic Growth Investments & Engineering drives efficiency of the Qulaity/Regulatory approach across the project portfolio; assures adequate staffing in the individual project team and escalates issues in an open and timely manner and taking leadership for their resolution.

Key responsibilities:

• Provide leadership for all Quality and Regulatory activities related to strategic growth engineering projects at Lonza, delivering accurate and timely input related to quality and regulatory aspects for projects.


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


• Make sure that decisions are fully supported by Lonza Global Quality as well as local Quality and Regulatory organizations.


• Implement a quality strategy for strategic growth aligned with Quality and Regulatory guidelines and entrepreneurial approaches.


• Support Strategic Growth Investment (SGI) in business related quality and compliance topics, including risk management.


• Ensure and facilitate the deployment of the quality strategy as approved by top management within SGI


• Active member of Lonza Global Quality Leadership Team and member of SGI Leadership Team


• Act as first contact within SGI for any Quality and Regulatory related topic. Ensure that new clients receive appropriate and complete information regarding Lonza’s quality systems


• Report progress of strategic growth projects within Lonza Global Quality. Communicate potential issues in an open and timely manner and take leadership for their resolution. Assessment of CARs to ensure that planned investments fulfil Quality and Regulatory requirements


• Ensure quality agreements with customers and suppliers are in place. Ensuring that customers have appropriate licenses and are authorized to purchase APIs and corresponding services.


• Supporting the sites in the collaboration with authorities and customers linked to strategic growth projects.


• Providing expertise and coaching, assisting sites and their teams for policies, procedures and specifications.


• Ensuring required Quality/Regulatory resources (and proper expertise) are available and effective at the sites to 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 and Regulatory functions with the goal to share best practices and to have one global quality system, where applicable.


• Supporting the movement away from traditional QA compliance practices towards new frameworks for the regulatory oversight of manufacturing quality based on quality systems and risk management approaches


• Closely follow industry trends and engage in industry associations to develop innovative future manufacturing concepts

Key requirements:

• Master’s Degree or equivalent experience ideally 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, experience in audit management and 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 planning and execution of large projects (resource planning, the timing of regulatory meetings with the inspection authorities, audit needs etc.)


• Knowledge of modern CQV approaches to minimize the time from construction completion to routine production while maintaining compliance


• Leadership role in operations readiness including the on boarding and training of new staff – both quality and operations.


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


• Strong verbal and written communication skills (German is advantageous).

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.

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

The Head of Quality, Strategic Growth Investments & Engineering is a new opportunity at Lonza. This position is responsible for all Quality and Regulatory aspects related to Strategic Growth Investments. It is a key position working with both leadership Quality organization and local Quality and Regulatory groups. The Head of Quality, Strategic Growth Investments & Engineering drives efficiency of the Qulaity/Regulatory approach across the project portfolio; assures adequate staffing in the individual project team and escalates issues in an open and timely manner and taking leadership for their resolution.

Key responsibilities:

• Provide leadership for all Quality and Regulatory activities related to strategic growth engineering projects at Lonza, delivering accurate and timely input related to quality and regulatory aspects for projects.


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


• Make sure that decisions are fully supported by Lonza Global Quality as well as local Quality and Regulatory organizations.


• Implement a quality strategy for strategic growth aligned with Quality and Regulatory guidelines and entrepreneurial approaches.


• Support Strategic Growth Investment (SGI) in business related quality and compliance topics, including risk management.


• Ensure and facilitate the deployment of the quality strategy as approved by top management within SGI


• Active member of Lonza Global Quality Leadership Team and member of SGI Leadership Team


• Act as first contact within SGI for any Quality and Regulatory related topic. Ensure that new clients receive appropriate and complete information regarding Lonza’s quality systems


• Report progress of strategic growth projects within Lonza Global Quality. Communicate potential issues in an open and timely manner and take leadership for their resolution. Assessment of CARs to ensure that planned investments fulfil Quality and Regulatory requirements


• Ensure quality agreements with customers and suppliers are in place. Ensuring that customers have appropriate licenses and are authorized to purchase APIs and corresponding services.


• Supporting the sites in the collaboration with authorities and customers linked to strategic growth projects.


• Providing expertise and coaching, assisting sites and their teams for policies, procedures and specifications.


• Ensuring required Quality/Regulatory resources (and proper expertise) are available and effective at the sites to 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 and Regulatory functions with the goal to share best practices and to have one global quality system, where applicable.


• Supporting the movement away from traditional QA compliance practices towards new frameworks for the regulatory oversight of manufacturing quality based on quality systems and risk management approaches


• Closely follow industry trends and engage in industry associations to develop innovative future manufacturing concepts

Key requirements:

• Master’s Degree or equivalent experience ideally 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, experience in audit management and 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 planning and execution of large projects (resource planning, the timing of regulatory meetings with the inspection authorities, audit needs etc.)


• Knowledge of modern CQV approaches to minimize the time from construction completion to routine production while maintaining compliance


• Leadership role in operations readiness including the on boarding and training of new staff – both quality and operations.


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


• Strong verbal and written communication skills (German is advantageous).

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.