Associate Director, Ge Commissioning and Qualification

Vor 3 Tagen


Stein, Schweiz Lonza Vollzeit

**Switzerland, Stein** Today, Lonza is a global leader in life sciences operating across five 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. We are hiring for a driven Global Engineering CQ Lead Shared Function (Commissioning, Qualification). In this role you will ensure that services and processes meet the regulatory requirements and quality standards. Join our ambitious team and help deliver world-class engineering projects. This is an outstanding opportunity to contribute to innovative CQ projects in Switzerland **Key responsibilities**: - Responsible for handling and leading a team of CQ experts. - Oversee the generation of all protocols for several projects such as life cycle documents. - Commissioning and qualification plan and report. - Oversee the alignment and execution of the IV/IQ static testing across all site projects. - The GE CQ Lead shared function will mainly support all the CQ Portfolio lead but also collaborates with other departments, such as engineering, manufacturing, quality, procurement and regulatory affairs, to ensure that CQ activities are increasing on efficiency regarding Cost and Timeline. - Oversee several remote offices which will be located in different strategic locations across the globe to increase efficiency and to reduce cost. - Be in charge to assess the capability and capacity of all suppliers quality department to ensure delivery of proper documentation in timely manner. - Collaborate with the different CQ Portfolio leads to ensure alignment on the documentation across all VISP projects. - Lead CQV activities to ensure compliance with regulatory requirements and industry standards. - Collaborate with cross-functional teams to identify and mitigate risks associated with CAPEX investments. - Provide technical leadership and guidance for CQV activities according to industry standards. - Develop and maintain relationships with key stakeholders for successful project execution. **Key requirements**: - Master Degree or equivalent experience in Pharma, Engineering, or Science - Proven experience in Pharma / Engineering (GEP/GMP) with an understanding of Fill and Finish Facility Building and processes. - Proven experience in Project Management, CQV - Proficient in English, German is an advantage - Understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGM - Strong leadership skills with a global interaction capability. - Possess financial and commercial acumen, able to link understanding to project goals, costs & scheduling, and risk. - Strong analytical skills for in-depth analysis of complex/large datasets, drawing conclusions and supporting decisions. - Can develop and implement new and standard processes, tools/methodologies in a global context, lead and train/support colleagues. **Why Lonza ?** 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. Inclusion is one of Lonza’s four core values, alongside integrity, innovation, and initiative. We understand the value of our differences and the benefits they bring to our company, community, and culture. We also recognize the value of every person’s contribution, regardless of characteristics, preferences, and beliefs - including race, color, ethnicity, sexual orientation, gender identity, and religion. Reference: R68574


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