Denmark Job Openings
Roche
Affiliate Quality Head Denmark, Norway & Sweden
Copenhagen
FULL TIME
November 3, 2024
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:
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Maintain ISO Certification: Ensure the ongoing ISO 9001:2015 certification and operational rights across Denmark, Norway, and Sweden.
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Strategic Quality Direction: Identify improvement opportunities and provide strategic Quality direction to Scandinavian General Managers, focusing on QMS performance, critical situations, and organizational needs.
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Audit Leadership: Conduct and lead internal and external audits (including third-party suppliers) as Lead Auditor, ensuring thorough follow-ups.
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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.
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Competent Authorities Liaison: Engage with Competent Authorities regarding Quality issues, ensuring appropriate stakeholder involvement.
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Quality System Strategy: Develop and maintain forward-looking Quality Management System and Certification strategies for all three countries.
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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.
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Training and Compliance: Ensure employee knowledge through effective training programs and monitor overall training compliance, proposing corrective actions as needed.
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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:
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BA/BS, MS, or Ph D in Life Sciences, Medical, or Engineering fields with 7-10 years of experience in a Quality-related role within Diagnostics/Healthcare/Pharma.
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Expertise in ISO 9001:2015 and comprehensive understanding of Scandinavian/Nordic healthcare systems.
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Proven ability to lead and work across complex networks or matrixed organizations, creating and implementing multi-country Quality strategies.
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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.
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Innovative and creative in contributing to local, Regional, and Global objectives, with a strong focus on exceeding customer and colleague expectations.
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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.
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Certified Lead Auditor or experienced in auditing is advantageous.
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Proficient in Microsoft Office, Google Workspace, and SAP
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Proficient in English and any Scandinavian Language (Swedish, Norwegian, or Danish).
Who we are
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.
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