We are looking for a Quality Systems Manager to join our Montpellier facility to participate in our on-going success as a financially sound, fast-growing, socially responsible company dedicated to Global Health.
As the Quality System Manager, you will Set, develop and guarantee the respect of the Quality Management System of MedinCell. Reporting to the Quality and Regulatory Compliance Director, you will maintain relationships with primary stakeholders.
Quality Management Systems
- Guarantee regulatory compliance of MedinCell
- Develop MedinCell Quality policy and strategy, and implement the adherence to Quality Best Practices
- Implement and improve current SOPs related to MedinCell Quality Management System (QMS)
- Participate in the application/implementation of the Quality standards related to products development of Manufacturing and testing Operations, inhouse and sub-contracted.
- Drive self-inspections related to QMS for the processes included in the relevant annual plans.
- Implement and track KPI of Quality activities.
- Lead annual Quality review
- Identify bottlenecks and proactively drive for their resolution
Operational Product Quality
- Represent the Quality Team in on assigned transversal project teams and contribute to the development of overall quality strategy
- Support Operational Quality Manager activities as ensuring that SOPs are followed during the in-house manufacturing and testing activities.
- Enhance the reputation of Medincell with external partners, authorities and the general public
- Develop solid relationships with Drug Product Development teams
- Work closely with Quality team members by embracing a collaborative work approach
- Write reports in English for use internally or with partners
- Participates actively to Regulatory Authorities inspections, partners/customers audits (including preparation)
- Ideally you hold a degree focused in life sciences with an industrial pharmaceutical focus
- Minimum 5 years of pharmaceutical experience (pharma/biopharma industry) in the Quality Assurance department
- Experience in computerized system validation would be highly desirable
- Knowledge of all GxP guidance
- Experience in pharmaceutical manufacture and testing
- Experience in multicultural environments and multidisciplinary teams
- Strong team spirit and open sharing of all the information necessary to successfully achieve overall work goals
- Experience in international and multidisciplinary teams is highly desirable