Quality Assurance & Regulatory Lead -In Vitro Diagnostic Regulation (IVDR)

La tua nuova azienda

The company is dedicated to offering cutting-edge cell-based products and services for advanced diagnostics, focusing on rare cells and their molecular characterization. Through its technologies, the company enables the detection and analysis of rare cells, supporting better diagnostic and therapeutic strategies for human health.

The Non-Invasive Prenatal Testing (NIPT) Department is dedicated to the development of an innovative clinical genomic testing platform. As the organization transitions from being R&D-focused to a fully operational commercial entity, there is a strategic effort underway to introduce this groundbreaking test into clinical practice, with the goal of transforming the landscape of prenatal testing.

Il tuo nuovo ruolo

The Quality Assurance Lead will be instrumental in the successful transition from research and development to pre-clinical implementativo, ensuring full adherence to regulatory requirements under the In Vitro Diagnostic Regulation (IVDR). This role will involve establishing a project-specific quality system for the R&D program and its transition to a clinic service laboratory. The QA lead will oversee quality practices and regulatory compliance ensuring that laboratory workflows align with the highest industry standards. The ideal candidate will have experience in developing and maintaining Quality Management Systems (QMS), process validation, and in-depth knowledge of IVDR regulations and compliance.

Main responsibilities:

1. Develop, implement, and maintain a robust Quality Management System (QMS) in accordance with ISO 13485, ISO 15189, and IVDR standards.
2. Ensure effective processes for document management, change control, risk management, and corrective and preventive actions (CAPA).
3. Lead internal and external audits, as well as regulatory inspections with Notified Bodies and regulatory authorities.
4. Write and maintain Standard Operating Procedures (SOPs) and quality documentation essential for regulatory submissions and certifications.
5. Collaborate closely with R&D teams to ensure the design and development of high-quality, robust workflows.
6. Support the transition to a clinical service laboratory during the pre-clinical phase, including the development and validation of laboratory procedures and the implementation of a comprehensive quality control program.
7. Train laboratory personnel on quality procedures, Good Laboratory Practices (GLP), and regulatory requirements.
8. Promote a culture of quality and continuous improvement throughout the organization.
9. Stay informed of evolving IVDR requirements, healthcare regulations, and industry best practices to ensure ongoing compliance.
10. Monitor industry trends and regulatory updates, proactively implementing necessary changes to the QMS.
11. Prepare and maintain technical documentation, including Design History Files (DHF), Device Master Records (DMR), in compliance with Regulation 2017/746 and applicable standards.
12. Collaborate with cross-functional teams to ensure all product development and clinical testing documentation meets ISO, IVDR, and in-house test standards.
13. Maintain comprehensive documentation for all quality assurance activities, including testing procedures, validation reports, regulatory filings, and audit records.
14. Prepare and deliver reports to senior management, highlighting quality performance, regulatory updates, and areas for improvement.
15. Lead risk management activities, including risk assessments and development of risk mitigation strategies in compliance with regulatory standards.
16. Oversee protocols for instrument qualification and validation, ensuring equipment meets the needs of R&D applications.
17. Monitor compliance with IVDR regulations throughout product development and pre-clinical implementativo.
18. Collaborate across functions to implement process improvements and uphold the highest standards of quality, efficiency, and compliance.
19. Serve as the main point of contact for quality assurance-related issues, providing leadership and guidance to cross-functional teams.
20. Support regulatory, pre-clinical, and commercial teams to align quality and compliance efforts across the organization.
21. Ensure smooth transfer of products from the design phase to production, ensuring production sites have accurate specifications, procedures, and work instructions.

Di cosa hai bisogno per aver successo

1. Bachelor's or Master's degree in Life Sciences, Medical Laboratory Sciences, Biotech, or related field.
2. Relevant certifications (e.g., ISO 13485, IVDR) are a plus.
3. At least 5 years of experience in quality assurance or quality management in the life sciences or medical device industry;
4. Strong knowledge of the In Vitro Diagnostic Regulation (Regulation 2017/746 -IVDR), ISO 13485, ISO 15189 and other relevant regulatory standards.
5. Strong leadership skills, enabling the management of cross-functional teams and ensuring collaboration across departments.
6. Excellent analytical, problem-solving, communication, and interpersonal skills.
7. Experience with laboratory operations, including assay development, validation, and quality control.
8. Excellent written and verbal communication in Italian and English, interpersonal, and organizational skills.
9. Ability to work independently and as part of a team.
10. Proficient in Microsoft Office Suite and other relevant software.

Location: Bologna

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#946469 - Emma Fossati