Affiliate Quality Head Denmark, Norway & Sweden

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position
At Roche, our mission is to improve the lives of patients through research and innovation, supporting high-quality care and precision medicine. We believe in fostering a cooperative and positive work environment where team members can thrive and contribute to our common goals.

We are seeking an Affiliate Quality Head Denmark, Norway & Sweden to join our Quality Assurance team. This role is critical in ensuring the highest standards of GMP/GDP Quality Management within our organization.

Join a team in a pleasant environment with engaged colleagues who want you to succeed!

The Opportunity:

• Maintain ISO Certification: Ensure the ongoing ISO 9001:2015 certification and operational rights across Denmark, Norway, and Sweden.
• Strategic Quality Direction: Identify improvement opportunities and provide strategic Quality direction to Scandinavian General Managers, focusing on QMS performance, critical situations, and organizational needs.
• Audit Leadership: Conduct and lead internal and external audits (including third-party suppliers) as Lead Auditor, ensuring thorough follow-ups.
• Quality Management Contact: Act as the primary point of contact for the Quality Management System for both internal and external stakeholders and authorities across all three countries.
• Competent Authorities Liaison: Engage with Competent Authorities regarding Quality issues, ensuring appropriate stakeholder involvement.
• Quality System Strategy: Develop and maintain forward-looking Quality Management System and Certification strategies for all three countries.
• Policy and Standard Oversight: Oversee the implementation of Roche Diagnostics policies, modular QMS Global Standard Processes, and maintain internal electronic Quality Process tools within Scandinavia.
• Training and Compliance: Ensure employee knowledge through effective training programs and monitor overall training compliance, proposing corrective actions as needed.
• Supplier Management: Qualify third-party suppliers and define roles and responsibilities related to complaint management and quality in compliance with IVDR/MDR.

Who You Are:

• BA/BS, MS, or PhD in Life Sciences, Medical, or Engineering fields with 7-10 years of experience in a Quality-related role within Diagnostics/Healthcare/Pharma.
• Expertise in ISO 9001:2015 and comprehensive understanding of Scandinavian/Nordic healthcare systems.
• Proven ability to lead and work across complex networks or matrixed organizations, creating and implementing multi-country Quality strategies.
• Strong diplomatic skills in conveying key requirements to stakeholders and demonstrated success in negotiation, with strong presentation and communication skills for translating complex Quality requirements.
• 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.
• Certified Lead Auditor or experienced in auditing is advantageous.
• Proficient in Microsoft Office, Google Workspace, and SAP
• Proficient in English and any Scandinavian Language (Swedish, Norwegian, or Danish).

Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Diagnostics A/S is the Danish affiliate of the Roche Group and employs approx. 90 highly qualified people. In recent years, Roche Diagnostics A/S has been developing rapidly, and the future looks promising.

Roche is an Equal Opportunity Employer.

Location: Copenhagen