Job Detail

Quality Assurance Project Manager Drug Substance, Ibex™

Inseriert am: 11.05.2020
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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.


For Ibex™ Solutions, our recently launched unique biological manufacturing and development concept in Visp, Switzerland, we have multiple openings. Become part of this exciting opportunity and join our team by applying for the position as QA Project Manager Drug Substance. In this role, you are a senior QA member with broad experience in the biotechnological manufacturing of drug substances and great expertise in cGMP, including international regulations.


Key responsibilities:



  • Provide QA oversights on all activities related to the establishment and transfer of manufacturing processes into the new biotechnological production.

  • Being involved in process transfers and represent the Quality Unit during all product life-cycles and as a deputy of the QA Team Leader

  • Facilitate discussions between customers and internal teams such as MSAT, Manufacturing, Engineering and QC

  • Review and approve Discrepancy Records and Change Requests

  • Manages the process for notifying the customer about discrepancies / change requests and assuring the customer’s feedback and relevant comments are addressed internally

  • Support the definition of preventive and corrective measures (CAPAs), approves them and tracks their timely implementation and effectiveness

  • Release Drug Substance batches

  • Review and approve SOPs and project related documents; supports and approves quality risk analysis (e.g. FMEA)

  • Support cGMP training programs to ensure staff is trained

  • Being involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department


Key requirements:



  • Bachelor, Master degree or PhD in chemistry, biotechnology, life sciences or related field

  • Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within the Quality Unit

  • Solution-oriented and strongly team-minded

  • Experience and success in setting up the training and learning efforts in a multicultural, international environment and organization

  • Ability to oversee project execution to identify non-compliance from quality standards

  • Structured, focused and well-organized working attitude

  • Open-minded for new ideas and suggestions

  • Excellent communication skills in English, German language skills are 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.

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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.


For Ibex™ Solutions, our recently launched unique biological manufacturing and development concept in Visp, Switzerland, we have multiple openings. Become part of this exciting opportunity and join our team by applying for the position as QA Project Manager Drug Substance. In this role, you are a senior QA member with broad experience in the biotechnological manufacturing of drug substances and great expertise in cGMP, including international regulations.


Key responsibilities:



  • Provide QA oversights on all activities related to the establishment and transfer of manufacturing processes into the new biotechnological production.

  • Being involved in process transfers and represent the Quality Unit during all product life-cycles and as a deputy of the QA Team Leader

  • Facilitate discussions between customers and internal teams such as MSAT, Manufacturing, Engineering and QC

  • Review and approve Discrepancy Records and Change Requests

  • Manages the process for notifying the customer about discrepancies / change requests and assuring the customer’s feedback and relevant comments are addressed internally

  • Support the definition of preventive and corrective measures (CAPAs), approves them and tracks their timely implementation and effectiveness

  • Release Drug Substance batches

  • Review and approve SOPs and project related documents; supports and approves quality risk analysis (e.g. FMEA)

  • Support cGMP training programs to ensure staff is trained

  • Being involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department


Key requirements:



  • Bachelor, Master degree or PhD in chemistry, biotechnology, life sciences or related field

  • Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within the Quality Unit

  • Solution-oriented and strongly team-minded

  • Experience and success in setting up the training and learning efforts in a multicultural, international environment and organization

  • Ability to oversee project execution to identify non-compliance from quality standards

  • Structured, focused and well-organized working attitude

  • Open-minded for new ideas and suggestions

  • Excellent communication skills in English, German language skills are 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.

Details