Associate Director, Quality Assurance
vor 7 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.
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 _Associate Director, Quality Assurance for Strategic Growth and Engineering 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 - 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’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: R54929**:
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