Affiliate Head of Quality and Regulatory Affairs - Roche Diagnostics job opportunity at Roche.

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DatePosted 24 Days Ago bot
Roche Affiliate Head of Quality and Regulatory Affairs - Roche Diagnostics
Experience: 10-years
Pattern: full-time
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loacation Hod Hasharon, Israel
loacation Hod Hasharon....Israel

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position We are seeking an Affiliate He ad of Quality a nd Regulatory Affairs to join our Roche Diagnostics team. This role is critical in ensuring the highest standards of GMP/GDP Quality Management within our organization. Your main purpose is to support internal and external stakeholders in the scope of quality management to continuously improve, monitor, and maintain the Quality Management System effectively, in accordance with applicable standards, Roche guidelines and local requirements.  The position is initially focusing on Israel and subsequently expanding oversight to other countries in the EMEA region. The Opportunity: Quality: Act as the primary point of contact for the Quality Management System for both internal and external stakeholders and authorities. Maintain ISO Certification : Ensure the ongoing ISO 9001:2015 certification and operational rights across Israel and potentially in other countries. Identify improvement opportunities and provide strategic Quality direction to Israel’s General Manager, focusing on QMS performance, critical situations, and organizational needs. Conduct and lead internal and external audits (including third-party suppliers) as Lead Auditor, ensuring thorough follow-ups. Engage with Competent Authorities regarding Quality issues, ensuring appropriate stakeholder involvement. Develop and maintain forward-looking Quality Management System and Certification strategies. Oversee the implementation of Roche Diagnostics policies, modular QMS Global Standard Processes, and maintain internal Quality Process tools. Ensure employee knowledge through effective training programs and monitor overall training compliance, proposing corrective actions as needed. Qualify third-party suppliers and define roles and responsibilities related to complaint management and quality in compliance with IVDR/MDR. Take end-to-end responsibility for non-conformities (NCs), CAPAs and supplier complaints (SCARs), utilizing process improvement techniques to address root causes and prevent recurrence. Responsible for supporting the implementation and continuous improvement of the global commercial Q&R strategy. Coach and support the Quality team members. Create a broad awareness in the organization on quality topics. Regulatory:  ● Responsibility for the regulatory processes of the company’s products, including regulatory approval of new products, changes in registration and renewal of existing licenses. ● Safeguard the affiliate’s License to Operate through strict adherence to local and international quality and regulatory standards. ● Responsibility for the localization of relevant packaging materials. ● Serves as liaison with internal/external customers including interaction with the Ministry of Health, Headquarters teams and international counterparts. ● Demonstrates leadership and commitment with respect to the QMS and with respect to customer focus. ● Ensures that roles and responsibilities are defined, that authorities for roles are assigned and resources are available. Who You Are: BA/BS, MS, or PhD in Life Sciences, Medical, or Engineering fields with 5-10 years of experience in a Quality-regulation related role, preferably within Diagnostics/Healthcare/Pharma. Experti se in ISO 9001:2015 and comprehensive understanding of Israel’s healthcare systems. Proven ability to lead and work across complex networks or matrixed organizations, creating and implementing multi-country Quality strategies. Innovative and creative in contributing to local, Regional, and Global objectives, with a strong focus on exceeding customer and colleague expectations. Familiarity with ISO 14001, ISO 13485, ISO 19011, ISO 27001, IVDR/MDR, GDP, GMP, or 21 CFR 820/803/807 is beneficial, along with understanding of IAF requirements for multi-site certification. Excellent written and verbal communication skills in Hebrew and in English. Certified Lead Auditor or experienced in auditing is advantageous.     Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

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