Director Digital Quality
vor 7 Monaten
**Director Digital Quality**:
**Location**
- Basel, Switzerland
**Business Sector**
- Biotechnology
**Job ref**
- 22276
**Published**
- about 5 hours ago
**Director Digital Quality**
Are you a professional with expertise in digital quality management within the Pharmaceutical and Biotechnology manufacturing industry? Join a top-tier organization in Northern Switzerland, celebrated for its groundbreaking contributions to pharmaceutical biotechnology. As the Director of Digital Quality, your leadership will be crucial in driving digital innovation in quality systems, ensuring adherence to the highest standards, and fostering a culture of continuous digital advancement and operational excellence.
**Tasks**
- Organization, management, and further development of an organizational unit in accordance with the management principles of a leading pharmaceutical company.
- Management and support of cross-site and strategic projects aimed at improving, harmonizing, and digitizing systems and processes.
- Provision of a global framework compliant with GAMP (Good Automated Manufacturing Practice) for computerized system validation, including corresponding procedures.
- Ensuring GAMP-compliant implementation and validation of new software systems (e.g., ensuring Quality Assurance (QA) involvement in projects, quality assurance of Computer System Validation (CSV) documents).
- QA oversight of GxP-relevant global software systems (e.g., enterprise resource planning, document management systems, laboratory information management systems, manufacturing execution systems) and ensuring their validated, controlled, and harmonized status.
- System owner/administrator responsibilities for the global quality management system.
- Conducting data evaluations, such as quality metrics.
- Monitoring technology trends and evaluating their applicability to the quality areas of the pharmaceutical industry; further development and expansion of digital capabilities in quality functions.
**Your Profile**
- Master's degree in natural science, computer science, or pharmaceutical engineering.
- Strong knowledge and/or practical experience in GMP (Good Manufacturing Practice) and GAMP, particularly in computerized system validation.
- At least 5-8 years of industry experience in the pharmaceutical sector, with a minimum of 3 years in project management, ideally across different sites in the life sciences sector.
- Proven leadership and stakeholder management skills.
- High service orientation towards internal and external customers, with a commitment to implementing this attitude across the organization.
- Business proficiency in English, both written and spoken. German language skills are an advantage.
**Interested?
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