Quality Manager
Cellply, Italy

Cellply is a life science tools company based in Bologna, Italy. We have developed and are launching a next generation analysis platform to transform cell therapy discovery, development and quality control using novel single cell approaches to carry out multi-parametric assays in parallel from the same sets of cells. We are creating the new standard for fast, automated, and multiplexed assays that puts more critical data in the hands of cell therapy researchers in basic science, pharma, release testing and beyond. Our first product is currently with customers in early access, and we are growing quickly and looking for an exceptional new team member to contribute to achieve high quality standards needed in our target markets and applications.

RESPONSIBILITIES AND DUTIES

The Quality Manager will be responsible of developing and maintaining a quality vision and culture across the different areas of the organization and develop a quality organizational structure, as the company grows.

Key responsibilities are to manage all aspects of quality including setting up and maintaining the Quality Management System obtaining an ISO:9001 certification, structuring and mapping critical processes required for product development, such as processes related to design control, software development lifecycle and risk management, setting up procedures ensuring proper control of product quality for instruments, consumables and software developed by Cellply. The Quality Manager will also ensure that product design and development will be carried out according to regulations and standards applicable to analytical instrumentation and quality control processes in the pharmaceutical industry, with specific reference to the ATMP (cell amp; gene therapy) field.

This position is available immediately. Quality manager will report to the CEO.

Functions

• Setup and maintain the Quality Management System according to ISO:9001 standards
• Promote a quality culture within the organization
• Ensure proper training of personnel on standard operating procedures and maintain a continuous improvement of the QMS
• Plan and carry out internal audits

• Provide an interface with external suppliers and audit external suppliers when needed
• Provide an interface to customers for all matters related to quality
• Support product design and development team by structuring design, validation, verification, and risk management processes according to relevant regulations
• Support the manufacturing team by structuring appropriate Quality Control processes at different steps of the manufacturing, following applicable standards and regulations
• Manage nonconformities identified during audits or generated during the manufacturing or by customers and define corrective actions

• Manage QMS data such as procedures, records, forms, issues, nonconformities and all critical data, information and knowledge within the company by defining appropriate workflows and tools, including digital platforms, for documentation approval, review, update
• Define a QA/QC organizational structure, identify new team members and manage the overall quality team
• Define KPIs working in collaboration with other departments and human resources area

Requirements

• Degree (BS/BA, MS, PhD) in life sciences or engineering fields
• 5 years of relevant experience in quality departments in structured companies

• Knowledge of ISO9001 is required
• Good knowledge of the English language is required
• Experience on analytical tools is a strong plus
• Experience in companies developing tools for the pharmaceutical industry is a strong plus
• Knowledge of 21 CFR Part 11 and relevant ISO standards for design and risk management is a strong plus

• Knowledge of GAMP guidelines is a plus

Benefits

• Work From Home: 2 days per week for a full-time position
• Health Insurance
• Training amp; Development

Job Rewards and Benefits