We are seeking an experienced Senior Quality Lead with a strong background in the pharmaceutical, biotechnology, or medical device industry. This role focuses on driving quality strategy, leading complex GxP audits, ensuring inspection readiness, and partnering with global stakeholders to maintain the highest quality and compliance standards. Location: Basel Contract: 1 year (extension possible) Tasks & Responsibilities Quality Strategy & Risk Management Develop and implement quality strategies across products, processes, and affiliates. Analyze quality data, identify trends and risks, and provide actionable insights. Establish strong partnerships with business stakeholders and define CtQ measures. Audits & Quality Assessments Lead complex GxP audits and quality assessments. Present audit findings, risks, and recommendations to senior stakeholders. Drive continuous improvement through quality oversight and risk-based decision making. Inspection Readiness & Compliance Lead inspection preparation and support health authority interactions. Deliver quality and compliance training to relevant teams. Ensure compliance with GxP regulations, including GCP, GVP, FDA, EU, and ICH requirements. Stakeholder Management & Continuous Improvement Collaborate across global functions to ensure quality standards are met. Lead quality initiatives and support the development of PDQ processes. Influence senior stakeholders and promote a culture of quality excellence. Requirements Bachelor's degree in a scientific or quality-related field; advanced degree preferred. Significant experience in the pharmaceutical, biotech, or medical device industry. Minimum 5 years of experience leading GxP audits and complex quality projects. Strong knowledge of GCP, GVP, IVD/MD regulations, drug development, and global regulatory requirements. Experience with audit management and quality reporting systems. Clinical Operations experience and/or quality experience in system validations. Excellent stakeholder management, communication, and leadership skills. Fluent in English; additional languages are an advantage. #J-18808-Ljbffr
Senior Quality Lead Arbeitgeber: Gi Group
Unser Unternehmen bietet Ihnen die Möglichkeit, in einem dynamischen und flexiblen Umfeld zu arbeiten, das Teamarbeit und persönliche Entwicklung fördert. Mit einer starken Präsenz in der Gesundheits- und Pflegebranche im Espace Mittelland unterstützen wir Sie dabei, Ihre Führungsfähigkeiten auszubauen und langfristige Kundenbeziehungen aufzubauen. Profitieren Sie von einem innovativen Arbeitsumfeld, das Ihnen nicht nur interessante Herausforderungen, sondern auch zahlreiche Weiterbildungsmöglichkeiten bietet.
