\\n Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there\\xe2\\x80\\x99s 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\\xe2\\x80\\x99s the kind of work we want to be part of.

In order to support the strategic growth investment of the company in Visp Switzerland, we are looking for an experienced quality professional who will be in charge of leading a team responsible for the quality oversight during Qualification activities of CAPEX projects (Detailed Design, C&Q), especially supporting the Biologics business.

The QA Associate Director \\xe2\\x80\\x93 CAPEX Projects (Biologics) (f/m/d) will manage a team of experienced quality professionals and be responsible to implement and manage capabilities that result in the success of the assigned investment projects.

Key responsibilities:

Manage all quality and compliance related responsibilities for the qualification of facilities, equipment and utilities for strategic growth investment projects (CAPEX
2 mCHF) during detailed design and C&Q Phases with focus on Biologics CAPEX

Managing a team of QA qualification managers and specialists. Provides leadership to the team with responsibility for all aspects of human resource management such as training, development, coaching and hiring

Strong contributor and vocal member of the Qualification and Validation BIO 1 leadership team

Review and approve qualification and compliance documents and records

Ensure that decisions are fully supported by global and local Quality and Regulatory

Ensure a strong quality mindset in the team and overall organization, through the implementation of a speak up culture to promote good quality practices

Escalating issues in an open and timely manner and taking leadership for their resolution

Key requirements:

Master or PhD in Pharmaceutical Sciences, Biochemistry, Chemistry or related field

Substantial work experience in a leadership role in Quality Assurance, Production or Engineering, in pharmaceutical industries and cGMP controlled environment

Profound knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems, as well as applicable guidelines (ISPE, ASTM)

Excellent knowledge of computer systems (e.g. TW, SAP, etc), quality tools such as risk based approaches \\xe2\\x80\\x93 FMEA, statistical process control, design of experiments and Six Sigma

Significant experience in project management, handling multiple projects and priorities simultaneously

Strong verbal and written communication skills in English, German is also preferred

Every day, Lonza\\xe2\\x80\\x99s 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.\\n \\n \\n \\n \\n \\n

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