Head of Quality and Customer Satisfaction
Il y a 5 mois
At
**Univercells**, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for all
At **Quantoom **Biosciences**, Univercells’s latest affiliate, we are on a mission to remove the barriers to making mRNA-based vaccines and therapeutics, at every stage from sequence up to mass production. We give our partners greater access to drug development and production autonomy through technical and business model innovation.
You will join an interdisciplinary team of passionate scientists, engineers, clinicians and corporate profiles committed to solving some of the biggest DNA and RNA production challenges facing vaccines and therapeutics. **Quantoom Biosciences** has two facilities; the headquarters are based in Nívelles (Belgium), and the France Research Center focusing on offering an end-to-end DNA production platform based in Evry (France).
In regards of our industrialization phase and the commercialization of our NfinityTM platform, we are looking to strengthen our quality department and have open a position as **Head of Quality and Customer Satisfaction **within Quantoom Biosciences
**MISSION**
The **Head of Quality and Customer Satisfaction** ensures the Quality of deliverables and compliance with regulations, customer requirements and operational performance. Our **Head of Quality and Customer Satisfaction** will be also responsible to support the definition of the strategy, the documentation management and the technical specifications.
As **Head of Quality and Customer Satisfaction**, you will manage our Quality team and also be an active contributor in the continuous improvement of the company to optimize his competitiveness i.e maintain, develop and adapt Quantoom Biosciences Quality system (ISO) in alignment with Univercells Group.
Our **Head of Quality and Customer Satisfaction** will have a good know-how of ISO quality system (GMP manufacturing standard is a plus) to support the organization and the Service Manager to answer requests on regulatory/Quality system aspects.
**RESPONSIBILITIES**
- Quality Management
- Define, maintain, continuously adapt, and improve Quality Systems for Quantoom Bioscience (Nívelles (Belgium) site and Evry (France) site in harmonization with Univercells Group.
- Support Quantoom’s teams to evaluate and take adequate remediation to quality issue, to manage customer complaints, change management
- Support supplier qualification with Univercells Group.
- Follow and adapt Processes to standards: engineering, ISO, Good scientific practices, clinical and preclinical regulations.
- Team Leadership
- Be an active member of Quantoom’s management Committee.
- Develop and maintain the team and evolution plan
- Set-up and follow individual collaborators development plan and clear responsabilities
- Harmonize the quality team between Nívelles and Evry sites.
- Develop a team mindset who’s focused on customer satisfaction and collaborative process builder and optimization.
- Qualification, Commissioning & Validation
- Support the organization for design, industrialization and I/OQ steps of UQTM’s equipment products (internally and externally)
- Support to define and continuously optimize the commissioning, qualification, validation & verification practices,
- Support process in qualification strategyfor our instrumentation,
- Support the design, the qualification, and the validation of the disposables
- Provide quality specification for the qualification (FAT/SAT) of equipment to ensure that design is efficient, documented and can be used in GMP environment (if applicable).
- Documentation
- Support the elaboration of all documents related to services and support to clients (installation, IQ/OQ support, validation, GMP-related processes)
- Provide advice and support for the preparation of customer related documentation (installation, operation, maintenance - user guide, maintenance manual, installation guide)
- Ensure adequate level of documentation and risk assessment to ensure our customer satisfaction about our product.
- Support Quantoom’s teams to build their documentation, to adapt their qualification strategy.
- Create, develop, and maintain Quantoom quality system documentation
- Engineering practices
- Follow & maintain engineering standards within the organization in support to equipment development team.
- Support traceability of industrialization approaches
- Act as a point of expertise when applicable
- HSE: be sure all rules and instructions in regards of EHS are respected and implemented.
**REQUIREMENTS - QUALIFICATIONS**
**Minimum required**:master’s degree (or higher) or equivalent acquired by experiencein Bioengineering, Biomedical Sciences or similar
- This position requires a strong commitment to excellence in quality and governance and outstanding leadership,
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