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Associate Director, Quality Control
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Regulatory Affairs Director
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Visp, Schweiz Lonza VollzeitJob SummaryWe are seeking an experienced Associate Director to provide regulatory and strategic guidance to internal and external customers for our Small Molecules business. The successful candidate will partner with stakeholders to prepare high-quality CMC submissions, oversee regulatory aspects of programs, and review change requests for manufacturing...
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Associate Director, Quality Control
vor 2 Wochen
Visp, Schweiz Lonza VollzeitToday, 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,...
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Associate Director, Quality Control
Vor 2 Tagen
Visp, Schweiz Lonza VollzeitToday, 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,...
Associate Director
vor 5 Monaten
Switzerland, VispToday, 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.
For our site in Visp we are looking for an Associate Director, Head CQV to set up and operate our new biopharma facilities. You will manage a team of CQV specialists with the responsibility to implement and manage CQV capabilities and activities that support the success of the assigned investment projects and the CQV activities during life cycle of the assets. In this role you will be a member of the Engineering and Maintenance Leadership Team Biologics.
**Key responsibilities**:
- Set up and implement the CQV strategy in the new facilities in alignment with the whole Lonza Visp site
- Manage a team of CQV and small device specialists. Provide leadership to the team with responsibility for all aspects of HR management such as qualification, development, coaching and hiring
- Responsibility for all required CQV activities of production equipment, utilities, clean rooms and small devices during the life cycle of the plants
- Ensure and manage the respective interfaces to the Manufacturing teams, QA, QC, Support Functions, Project
- and Site Engineering teams
- Responsibility for delivering all input required for the use of CQV tools for construction, commissioning and qualification of Ibex biopharma facilities
- Support all Quality and Compliance related responsibilities for the commissioning/qualification/validation of facilities, equipment, utilities and systems (incl. CSV) related to the cGMP manufacture in multiple plants
- Responsiblility and support the preparation of GMP risk assessments and introduce expertise into these risk analysis
- Write, review and approve CQV documents (e.g. URS, DC/DQ/IC/IQ/OC/OQ/PT/PQ Plan and Reports, CSV documentation
- Review technical change requests during the different phases of a project and during the life cycle and assesses their relevance to the CQV activities of facilities, equipment, utilities and systems.
- Represent specific areas as Subject Matter Expert (SME) and provide guidance and recommendations in these areas to internal or external customers
- Support continuous improvements programs to establish an effective CQV System
**Key requirements**:
- University Degree in the area of Mechanical Engineering/Chemical
- or Biological Process Engineering or similar
- Profound experience in GMP and CQV activities of biopharmaceutical plants. Recognized expert in the area of CQV activities for biopharma production units
- Deep experience with CQ activities according V-Model and the science and risk-based process
- Good knowledge of engineering and manufacturing processes
- Strong leadership skills and team orientation
- Ability to communicate internally and externally at higher levels; strong business understanding
- Structured, focused and well-organized working attitude
- Fluent in German and English
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.
**Reference: R54392**:
