Quality Assurance Manager m/f (JN -112021-4532343) Basel-Country, Switzerland
| Salary: | CHF130000 - CHF160000 per annum |
• Assure the overall management of all aspects of the Quality Assurance System to secure overall regulatory compliance to GMP (EU/US) at all times for the entire site
• Optimize the actual quality system to guarantee complete QA overview,
• Responsible for defining the QA strategy and its implementation
• Provide leadership and manage a team of about 20 persons
• Be an escalation and decision point for all matters related to quality
• Heading of the GMP Quality Assurance Team and management of that team covering all GMP related activities, such as:
- Organization of QM systems for deviations, CAPAs, changes, OOS and complaints according to GMP regulations
- Hosting external client audits and inspections of health authorities
- Planning, implementation and follow-up of corrective actions resulting from audits and authority inspections
- Regular reporting to senior management,
- Securing the compliance according to client requirements together with relevant internal stakeholders (e.g. Head of Production, Head of QC, Responsible Person (QP), group leaders, project managers)
- Organize and assure in a proactive manner the follow-up of the EU and US regulatory environment trends and evolutions