Associate Director, Quality, Project Delivery Visp - Global Quality
Lonza
Visp, Switzerland
Key responsibilities:
- Lead all Quality and Compliance related responsibilities for CAPEX Projects (CAPEX > 2 mCHF);
- Leading a team of QA qualification specialists. Provides leadership to the Team with responsibility for all aspects of human resource management such as training, development, coaching and hiring;
- Be a member of the Global Quality Engineering Leadership team;
- Review and approve qualification and compliance documents and records;
- Ensure that decisions are fully supported by global and local Quality and Regulatory;
- Raising issues in an open and timely manner and taking leadership for their resolution.
Key requirements:
- Academic degree (Master or higher) 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;
- Experience working on CAPEX projects (ideally within small molecule area);
- Profound knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems, as well as applicable guidelines (e.g. GAMP5);
- Knowledge of Computer System Validation, Commissioning & Qualification is a solid advantage;
- Strong collaborative approach, organizational skills, ability to balance multiple priorities simultaneously, ability to solve problems, understanding details and strategic picture, providing practical solutions;
- Fluent in English, German is a plus.
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