Associate Director, Quality Control

vor 2 Monaten

Visp, Schweiz Lonza Vollzeit
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.This position is based in the beautiful town of Visp. As an Associate Director Quality Control (QC) Projects you will be responsible for the operational aspects of all projects within the business unit Mammalian, specifically for the risk and issues management. This means that you will anticipate any risks, address them as needed (mitigation plans) as to prevent escalations. This way you will ensure the smooth operation of various mammalian QC projects. Please note that this is an individual contributor role (no direct reports).Key responsibilities:Responsible for overseeing QC projects in the early phases and commercial Mammalian projects, from demand to supply to stakeholders.Ensure that monthly deliverables are closely tracked and On Time In Full (OTIF) is secured.Align with Lab heads for Quarterly OTIF deliverables and anticipate risks and plan for Mitigation strategy. Responsible to closely track the progress of critical deliverables having financial impact on business.Ensure operational readiness of QC (internal and external) for Process Performance Qualification (PPQ) projects.Serve as a single point of contact for Project Management (PM) leads for escalations, risks, and issues. Serve as a single point of contact for reviewing business proposals and ensure that work-packages can be delivered by QC within the agreed time frame with the business.Collaborate with internal QC Labs and external partners to mitigate delays and provide necessary support. Responsible to follow up with labs for

OOS, Deviations

which has an impact on batch release timelinesHandle daily operational batch release updates, progress and effectively communicate with Manufacturing Science and Technology (MSAT), Operations, and Quality teams.Connect Mammalian Manufacturing demand to QC and flag risks in capacity planning meetings.Highlight the anticipated risk to the Project Management that impacts the service delivery.Key requirements:MSc or PhD in Life Science Biochemistry/Biotechnology with significant work experience in the GxP controlled Biologics/Biopharmaceutical/Pharmaceutical industry is a mustDemonstrated stakeholder management skills (collaborating with various types of stakeholders). You enjoy risk and issue management. You enjoy challenges and you are eager to make an impact to our organisation. You also enjoy working in a dynamic environment.Strong problem solving and scientific project management skills (experience in applying Lean methodologies is a plus, e.g. 5Why, 6M)In depth knowledge of QC lab operations and requirements of GxP Regulations and guidance of Health Canada, US-FDA, EU in particular data integrity and various compendia (USP, EP, JP)Fluency in English is a must, communication skills in German are an advantageRelocation assistance is available for eligible candidates and their families, if needed.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.SummaryLocation: CH - VispType: Full time

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